| CTRI Number |
CTRI/2024/11/077274 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
This study is being done to compare the effect of pre-operative nebulization with Dexmedetomidine, Lidocaine and a combination of Dexmedetomidine and Lidocaine for prevention of stress respone to laryngoscopy and intubation in patients posted for elective surgeries under General Anaesthesia |
|
Scientific Title of Study
|
Efficacy of pre-operative nebulization with Dexmedetomidine, Lidocaine and a combination of dexmedetomidine and lidocaine for prevention of stress response to laryngoscopy and 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 Sagnik Datta Majumdar |
| Designation |
Junior Resident |
| Affiliation |
Chirayu Medical College & Hospital, Bhopal |
| Address |
Department of Anaesthesiology
Chirayu Medical College & Hospital
Bhopal
Bhopal MADHYA PRADESH 462030 India |
| Phone |
9754151325 |
| Fax |
|
| Email |
sagnikdattamajumdar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arushi Dua |
| Designation |
Senior Resident |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College & Hospital
Bhopal
Bhopal MADHYA PRADESH 462030 India |
| Phone |
7000273969 |
| Fax |
|
| Email |
dr.arushi25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arushi Dua |
| Designation |
Senior Resident |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College & Hospital
Bhopal
MADHYA PRADESH 462030 India |
| Phone |
7000273969 |
| Fax |
|
| Email |
dr.arushi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chirayu Medical College and Hospital
Bhopal 462030
Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Chirayu Medical College and Hospital |
| Address |
CMCH
Bhopal 462030
Madhya Pradesh India |
| Type of Sponsor |
Private 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 Sagnik Datta Majumdar |
Chirayu Medical College and Hospital |
Main OT Complex
Department of Anaesthesiology Third Floor
CMCH
Bhopal 462030 Bhopal MADHYA PRADESH |
9754151325
sagnikdattamajumdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chirayu Medical College and Hospital |
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 |
| Intervention |
Dexmedetomidine |
Nebulization with 50 mcg diluted upto 5 ml with 0.9% Normal Saline. |
| Comparator Agent |
Dexmedetomidine and Lidocaine |
Nebulization with a combination of 50 mcg Dexmedetomidine and 3ml of 4% Lidocaine diluted upto 5ml with 0.9% Normal Saline. |
| Comparator Agent |
Lidocaine |
Nebulization with 3 ml of 4% Lidocaine diluted upto 5 ml of 0.9% Normal Saline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Physical Status Grades 1 and 2
Patients undergoing elective surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA physical status 3 or more
Body Mass Index more than 30 kilograms per square metre
Emergency surgery
Patients with anticipated difficult intubation
Patients with unanticipated difficult intubation requiring more than 15 seconds or more than 1 attempt at laryngoscopy
Known allergy to study drugs
Patients on Antihypertensives or drugs which can be a cofounder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HR, SBP, DBP, MAP, SpO2 |
1, 3, 5, 7 and 10 minutes post-intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation level will be assessed using Ramsay Sedation scale. |
Before and after Nebulization |
|
|
Target Sample Size
|
Total Sample Size="174" Sample Size from India="174"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="0" Months="8" 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
|
Direct laryngoscopy and tracheal intubation following induction of anesthesia are associated with hemodynamic changes due to increased sympathoadrenal activity, which may result in hypertension and/or tachycardia. Although transient, this exaggerated response may precipitate hypertensive crises, myocardial ischemia, arrhythmias, or increase in intracranial pressure in susceptible individuals. Various drugs—including local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics—have been tried to blunt the laryngoscopy and intubation response, with varied success. Nebulisation with lignocaine has a direct inhibition of the airway reflexes and thus useful in prevention of stress response. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its pleiotropic effects have led to its increasing use for reducing anaesthetic and analgesic requirements in the perioperative period. The efficacy of dexmedetomidine in decreasing the hemodynamic response to laryngoscopy and intubation has been studied through intravenous intranasal and intramuscular routes. Nebulized dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa. Multiple studies had compared intravenous dexmedetomidine and nebulized lignocaine for prevention of stress response to intubation, but limited literature had compared nebulized dexmedetomidine and lignocaine. The present study aims to compare the effect of pre-operative nebulization with dexmedetomidine and lignocaine on stress response to laryngoscopy and intubation. | |