| CTRI Number |
CTRI/2025/09/094340 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study between the effects of two doses of nebulized Dexmedetomidine as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation in a tertiary care hospital |
|
Scientific Title of Study
|
A Comparative study between the effects of two doses of nebulized Dexmedetomidine as a premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. D G Rakshitha |
| Designation |
2 nd year Post graduate |
| Affiliation |
Kodagu institute of medical scinces |
| Address |
Department of Anaesthesia
Kodagu institute of medical scinces,
near G T Circle
Kodagu KARNATAKA 571201 India |
| Phone |
7892746957 |
| Fax |
|
| Email |
raksharh6@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Aiyappa D S |
| Designation |
Associate Professor |
| Affiliation |
Kodagu institute of medical scinces |
| Address |
Department of Anaesthesia
Kodagu institute of medical scinces,
Near G T circle
Kodagu KARNATAKA 571201 India |
| Phone |
9986336771 |
| Fax |
|
| Email |
draiyappads@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Aiyappa D S |
| Designation |
Associate Professor |
| Affiliation |
Kodagu institute of medical scinces |
| Address |
Department of Anaesthesia
Kodagu institute of medical scinces,
Near G T Circle
Kodagu KARNATAKA 571201 India |
| Phone |
9986336771 |
| Fax |
|
| Email |
draiyappads@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu institute of medical scinces,
near G T Circle
madikeri, Karnataka, India
Pin code: 571201
|
|
|
Primary Sponsor
|
| Name |
Dr D G Rakshitha |
| Address |
Kodagu institute of medical scinces, near G T Circle madikeri, Karnataka, India.
Pin code: 571201 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D G Rakshitha |
Kodagu institute of medical sciences |
Department of Anaesthesia
Kodagu institute of medical sciences
Near G T Circle, Madikeri
Karnataka
India
Pin code: 571201 Kodagu KARNATAKA |
7892746957
raksharh6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kodagu institute of medical sciences Madikeri 571201 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulized dexmedetomidine 1 mcg/kg as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation |
Comparison of 1 mcg/kg nebulized dexmedetomidine as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation.
Patients will receive nebulized dexmedetomidine at a dose of 1 mcg/kg, diluted to 5 ml, administered over 10 minutes using an electric compressor nebulizer, 30 minutes prior to induction of general anesthesia. The effect of the intervention will be monitored until 10 minutes after endotracheal intubation. Thus, the total duration of intervention is approximately 40 minutes.
|
| Intervention |
Nebulized dexmedetomidine 2 mcg/kg as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation
|
Comparison of 2 mcg/kg nebulized dexmedetomidine as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation.
Patients will receive nebulized dexmedetomidine at a dose of 1 mcg/kg, diluted to 5 ml, administered over 10 minutes using an electric compressor nebulizer, 30 minutes prior to induction of general anesthesia. The effect of the intervention will be monitored until 10 minutes after endotracheal intubation. Thus, the total duration of intervention is approximately 40 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgeries under General Anaesthesia with endotracheal
intubation
2. Patients belonging to American society of anaesthesiologist (ASA) Physical status (PS) grade 1 and 2
3. Mallampati class 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway
2. Patients with history of allergic reaction to Dexmedetomidine
3. Patient taking medications that alters the heart rate such as Beta-blockers and Clonidine
4. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the changes in Mean arterial pressure (MAP) as a component of haemodynamic stress response to laryngoscope and intubation with two doses, 1 mcg/kg versus 2 mcg/kg of nebulised Dexmedetomidine |
Post-intubation at 1 minute, 2 minutes, 3minutes, 4 minutes, 5 minutes, 6 minutes, 8 minutes and 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the dose sparing effect of nebulised Dexmedetomidine on the amount of Propofol used during induction of General anaesthesia. |
Propofol induction
dose(mg/kg) during induction of general anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation is one of the methods of securing airway before performing surgical procedure requiring General Anaesthesia. The most commonly used equipment to aid endotracheal intubation is a laryngoscope, and the procedure performed is known as laryngoscopy. Laryngoscopy and endotracheal intubation are noxious stimuli, associated with transient but significant hemodynamic changes, termed as pressor/hemodynamic response. Hemodynamic changes Starts within 1 minute lasting upto 10 minutes. Cardiovascular changes occur primarily through reflex response. In Adults most common response to Airway manipulation is hypertension and tachycardia mediated by the cardioaccelerator nerves and sympathetic chain ganglia. Various agents in the form of opioid analgesics, benzodiazepines, beta blockers, calcium channel blockers, and vasodilators have been tried till now to attenuate the hemodynamic respone to Laryngoscopy and Endotracheal Intubation but none of them proved to be Ideal Dexmedetomidine is Dextro isomer and pharmacologically active component of Medetomidine , It an Alpha 2 Adrenergic agonist which inhibits Pontine ceruleus, an important noradrenergic nucleus mediating Sympathetic nervous system function, vigilance, memory, analgesia , arousal. Dexmedetomidine is used as an adjuvant for premedication, especially in patients susceptible to preoperative and perioperative stress because of its sedative, anxiolytic, analgesic, sympatholytic, and stable hemodynamic profile. Dexmedetomidine decreases oxygen consumption in intraoperative period (up to 8%) and in postoperative period (up to 17%), reduces the extent of myocardial ischemia during cardiac surgery. It also has respiratory-sparing effects. Dexmedetomidine has been shown to provide good perioperative haemodynamic stability with decreased intraoperative opioid requirements. Dexmedetomidine reduces sympathetic response to surgery by activating peripheral presynaptic α2- AR which reduces the release of catecholamines.
Most common route of administration of Dexmedetomidine is Intravenous route but is associated with adverse effects such as Bradycardia and Hypotension, Other routes of administration include Intramuscular and Intranasal. Nebulised Dexmedetomidine is a non invasive method, with good bioavailability ( nasal mucosa accounts for 65 % and buccal mucosa accounts for 82% )and rapid absorption. Recent studies using nebulised Dexmedetomidine suggested it to be a novel route of Dexmedetomidine administration . Nebulised dexmedetomidine have been used in various studies to attenuate the intubation stress response. To the best of our knowledge limited studies are available comparing the effects of different doses of nebulised dexmedetomidine in attenuation of haemodynamic stress response |