Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation

The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult
• Intervention / Treatment: Drug: dexmedetomidine group; Drug: remifentanil group

Detailed Description

Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai JiaoTong University, School of Medicine
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery

Exclusion Criteria:

• pregnant or lactating female,
• long-term opioids or sedative medication,
• patients < 18 years of age,
• severe bradycardia (HR < 50 beats/min),
• hypotension (systolic pressure < 90mmHg),
• any type of atrioventricular block on the ECG

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dexmedetomidine; a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h	Drug: dexmedetomidine group; 1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine; Other Names: Dexmedetomidine Hydrochloride Injection
ACTIVE_COMPARATOR: remifentanil; The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived.	Drug: remifentanil group; target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration); Other Names: Remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopy Scores	Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition. Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing	during the procedure of fibreoptic and tracheal intubation
Intubation Score	graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing	during the inserting of the tracheal tube

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Reaction to Procedure	Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level. Clinical score Level of sedation; Patient is anxious and agitated or restless, or both; Patient is cooperative, oriented and tranquil; Patient responds to commands only; Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus; Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus; Patient exhibits no response to stimuli	the duration of intubation, an expected average of 10 minutes
Post Operative Visit	visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.	24 hours
Mean Arterial Blood Pressure	MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.	15 minutes before intubation, endoscopy point, intubation point
Heart Rate	Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.	15 minutes before intubation, endoscopy point, intubation point
Peripheral Oxygen Saturation(SPO2)	Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.	15 minutes before intubation, endoscopy point, intubation point
Cardiac Rhythm	Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.	15 minutes before intubation and duration of intubation
Post Intubation Score	Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome. Post-intubation score 1 2 3; Cooperative, obeying commands; Uncomfortable, GA imminent; Other（specify）	immediately after the intubation

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Chair: Hong Jiang, MD, PHD, Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (ESTIMATE): November 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 21, 2012
• Last Update Submitted That Met QC Criteria: October 22, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: adult; dexmedetomidine; remifentanil; difficult airway; awake nasotracheal fibreoptic intubation; oral maxillofacial surgery
• Additional Relevant MeSH Terms: 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; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: JYMZK-002