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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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