Intranasal Dexmedetomidine Premedication

A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy

Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.

Study Overview

• Status: Completed
• Conditions: Benign Neoplasm of Vocal Fold - Glottis
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: placebo

Detailed Description

All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First Municipal People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Surgery:The laryngoscope vocal polyp excision
• Aged 18 to 60 years old
• Body mass index (BMI) < 30 kg/m2
• American society of Anesthesiologist (ASA) I -II

Exclusion Criteria:

• The investigator refused to participate
• Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
• With previous history of heart disease
• Pregnant women; no reliable contraceptive measures in postmenopausal women
• Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
• Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
• Asthma
• Sleep apnea syndrome
• Liver and kidney dysfunction
• Known to suffer from mental illness
• Long-term use of sedatives and analgesics in patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexmedetomidine; intranasal dexmedetomidine	Drug: Dexmedetomidine; intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.; Other Names: intranasal dexmedetomidine
Placebo Comparator: placebo; intranasal saline	Drug: placebo; 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation Time After Intranasal Dexmedetomidine Premedication	The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration	1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine	Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine. Modified Observer's Assessment of Alertness/Sedation Scale: 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus.	1 days
Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine	Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.	1 day
Number of Participants With Anxiety Score >2	satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction. Anxiety score >2 was considered to be better for the patient.	1 day
Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine	4-point anxiety score: = combative; = anxious; = calm; = amiable. Anxiety score >2 was considered to be better for the preoperative patients.	1 day
Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine	Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.	1 day
Number of Participants With Satisfaction Score <2	Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU). Satisfaction score <2 was considered to be better for the patient	1 day
Perioperative Bradycardia Episodes	Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.	1 day
Perioperative Tachycardia Episodes	Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.	1 day
Perioperative Hypotension Episodes	Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.	1 day
Perioperative Hypertonsion Episodes	Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo	Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo	1 day
Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine	Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine	1 day
Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo	Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo	1 day
Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine	Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo	1 day
Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine	Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine	1 day
Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine	American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine. ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation. ASA III: A patient with severe systemic disease that results in functional impairment. ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation. ASA VI: Declared brain death patient whose organs are being harvested for transplantation.	1 day
Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo	Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo	1 day
Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine	Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine	1 day
Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo	Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo	1 day
Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine	Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.	1 day
Duration of Anesthesia of Patients Receiving Intranasal Placebo	Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending	1 day
Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine	Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending	1 day
Duration of Surgery of Patients Receiving Intranasal Placebo	Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending	1 day
Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine	Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending	1 day
Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs	Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus	1 day
Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs	Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus	1 day
Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction	Modified OAA/S score of patients receiving intranasal placebo at Pre-induction. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score): 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus	1 day
Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction	Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score): 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus	1 day
Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation	Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus	1 day
Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation	Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score): 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus	1 day
Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs	Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)	1 day
Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs	Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)	1 day
Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction	Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)	1 day
Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction	Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)	1 day
Satisfaction Scores of Patients Receiving Intranasal Placebo	Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).	1 day
Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine	Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).	1 day
Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo	Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation	1 day
Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine	Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation	1 day
Time to Consciousness of Patients Receiving Intranasal Placebo	Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.	1 day
Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine	Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.	1 day
Time to Extubation of Patients Receiving Intranasal Placebo	Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation	1 day
Time to Extubation of Patients Receiving Intranasal Dexmedetomidine	Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation	Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation. Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation	Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope	Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope	Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope	Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope	Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing	Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing	Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence	Predicted effect-site concentrations of propofol after intranasal placebo at emergence. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence	Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation	Predicted effect-site concentrations of propofol after intranasal placebo at extubation. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation	Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation. Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation	Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation	Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope	Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope	Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope	Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope	Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing	Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing	Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence	Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence	Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation	Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation	Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation. Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator	1 day
HR in the Placebo Group Before Intranasal Drugs	HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room	1 day
HR in the Dexmedetomidine Group Before Intranasal Drugs	HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room	1 day
HR in the Placebo Group at Pre-induction	HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room	1 day
HR in the Dexmedetomidine Group at Pre-induction	HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room	1 day
Number of Participants With VAS >50	Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.	1 day
Patients With Postoperative Nausea in Two Groups	Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.	1 day
Patients With Postoperative Vomiting in Two Groups	Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.	1 day
Patients With Postoperative Shivering in Two Groups	Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering	1 day
Patients With Intra-operative Awareness in Two Groups	Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine	1 day
Visual Analogue Scale (VAS) in the Placebo Group	An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.	1 day
Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group	An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.	1 day

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital
• Investigators: Principal Investigator: Xiangcai Ruan, MD, PHD, Guangzhou First Municipal People's Hospital,Guangzhou Medical College

Publications and helpful links

General Publications

• Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
• Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
• Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
• Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
• Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.
• Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
• Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.
• Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.
• Lu C, Zhang LM, Zhang Y, Ying Y, Li L, Xu L, Ruan X. Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study. PLoS One. 2016 May 19;11(5):e0154192. doi: 10.1371/journal.pone.0154192. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 30, 2014
• First Submitted That Met QC Criteria: April 5, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: February 13, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: intranasal; dexmedetomidine; early recovery; suspension laryngoscopy
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: GZFPH-IRB-2013-086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No