Attenuation Of Hemodynamic Response To Laryngoscopy. Role Of Dexmedetomidine. A Dose Finding Study

Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress response to laryngoscopy in American Society of Anesthesiology, physical class I patients which will be compared with the placebo-controlled group.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Hemodynamic Instability; Tracheal Intubation
• Intervention / Treatment: Drug: Normal saline; Drug: Dexmedetomidine 0.5 microgram/kg; Drug: Dexmedetomidine 0.75 microgram/kg

Detailed Description

A randomized, double-blind controlled trial will be conducted to determine the attenuation of stress response caused by laryngoscopy and tracheal intubation (LTI). After the Institutional Ethics Committee approval, (Sindh Institute of Urology and Transplantation, Pakistan), written informed consent will be obtained from 105 adult patients.

Randomization will be done using a computer-generated random number table. Patients will be divided into three groups. Group A "Placebo group", will receive 20 mL of normal saline (NS), Group B "dexmedetomidine 0.5", will receive dexmedetomidine 0.5 μ/kg, whereas, Group C "dexmedetomidine 0.75", will receive dexmedetomidine 0.75 μ/kg, all as a 20mL infusion through a syringe pump over 10 minutes followed by induction of general anesthesia.

No premedication will be given in the ward. Once the patients will arrive in the operating room, routine monitoring (electrocardiogram, pulse oximetry, non-invasive blood pressure) will be started. After recording the baseline vitals and Ramsay sedation score, the study drug or normal saline (according to randomization) will be given in a look-alike syringe over 10 minutes. The study drug will be prepared as a 20 mL solution in a 25 mL syringe. An independent co-investigator (anaesthesiologist) who will not be involved in administering general anesthesia or recording the study parameters will prepare the study drug(s) according to the body weight or NS using identical-looking syringes. Study drug infusion will be started once the patient is taken to the operating table. Vitals and sedation scores will be recorded at 0,1,3,5 and 10 minutes during infusion. Investigators will keep the atropine drawn in a syringe and ready to be given in case of heart rate goes below 40 beats/min. Ephedrine (5mg/ml) and adrenaline 10µ/ml will also be ready for use.

Once completing the infusion, general anesthesia will be administered using a standard protocol (Nalbuphine 0.15 mg/kg, Propofol 2.5 mg/kg, Atracurium 0.6 mg/kg after assessing easy bag-mask ventilation in all patients. After 3-minute bag-mask ventilation with Isoflurane at 1.5% in 100% oxygen, the trachea will be intubated by one of three senior anaesthesiologists involved in this study. The intubating duration will be kept below 15 seconds. Hemodynamic monitoring will be continued for another 10 minutes at 1, 3, 5 and 10 minutes after intubating the trachea.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Syed Muhammad Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 to 55 years
• ASA I or II patients undergoing surgery under general anaesthesia with endotracheal intubation.
• Patients with Mallampati class I or II.

Exclusion Criteria:

• ASA III & IV patients
• Anticipated or unanticipated difficult intubations which requires more than 15 seconds or more than one attempt.
• Patients with Mallampati class III, IV or with loose teeth.
• Patients with inotropes infusion.
• Patients with known allergy to any anaesthetic agents
• Patients with a heart rate of 60 beats/min or less
• Patients with known hypertension, incidental finding of hypertension while on operating table, diabetes, ischemic heart disease or peripheral vascular disease.
• Pregnant and lactating mothers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine 0.5; Dexmedetomidine 0.5 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia.	Drug: Normal saline; Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes; Other Names: Placebo group; Drug: Dexmedetomidine 0.5 microgram/kg; Dexmedetomidine 0.5 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Active Comparator: Dexmedetomidine 0.75; Dexmedetomidine 0.75 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia.	Drug: Normal saline; Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes; Other Names: Placebo group; Drug: Dexmedetomidine 0.75 microgram/kg; Dexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Placebo Comparator: Placebo; 20 mL of normal saline as an infusion through a syringe pump over 10 minutes followed by induction of general anesthesia.	Drug: Normal saline; Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes; Other Names: Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Response	Mean change in the heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be assessed.	0 to 10 minutes after endotracheal intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events after intervention such as drowsiness, nausea, vomiting, or severe bradycardia will be observed.	0 to 30 minutes from the start of infusion to 10 minutes after endotracheal intubation)

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Principal Investigator: Syed M Abbas, Associate Professor Dept of Anaesthesia

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Sedation; Laryngoscopy; Heart Rate; Precedex; Tracheal Intubation; Systolic Blood Pressure; Mean Arterial Pressure; Diastolic Blood Pressure
• 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; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: SindhInstitute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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