FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082972 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomized, double-blind study comparing the effectiveness of inhaled dexmedetomidine versus lidocaine in minimizing coughing and discomfort during extubation (breathing tube removal) following general anesthesia for surgery. 
Scientific Title of Study   COMPARISON OF IN-LINE NEBULISATION WITH DEXMEDETOMIDINE VERSUS 2% XYLOCARD PRIOR TO EXTUBATION ON EXTUBATION RESPONSE IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA- A RANDOMIZED DOUBLE BLIND CLINICAL TRIAL. 
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 MADHU PRIYA V 
Designation  MD ANAESTHESIOLOGY AND INTENSIVE CARE 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA, NIZAMS INSTITUTE OF MEDICAL SCIENCES.

Hyderabad
TELANGANA
500082
India 
Phone  8056013924  
Fax    
Email  madhuvenkat96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KANITHI GEETA 
Designation  MD ANAESTHESIOLOGY 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, NIZAMS INSTITUTE OF MEDICAL SCIENCES

Hyderabad
TELANGANA
500082
India 
Phone  9849264451  
Fax    
Email  drgeeta3007@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MADHU PRIYA V 
Designation  MD ANAESTHESIOLOGY AND INTENSIVE CARE 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA, NIZAMS INSTITUTE OF MEDICAL SCIENCES.

Hyderabad
TELANGANA
500082
India 
Phone  8056013924  
Fax    
Email  madhuvenkat96@gmail.com  
 
Source of Monetary or Material Support  
NIZAMS INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA MARKET ROAD, PUNJAGUTTA, HYDERABAD - 500 082 
Type of Sponsor  Government 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 MADHU PRIYA V  NIZAMS INSTITUTE OF MEDICAL SCIENCES  DEPARTMENT OF ANAESTHESIA, NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA MARKET ROAD, PUNJAGUTTA, HYDERABAD.
Hyderabad
TELANGANA 		 8056013924

madhuvenkat96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PATIENTS COMING FOR SURGERIES UNDER GENERAL ANAESTHESIA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% LIDOCAINE NEBULISATION  Lidocaine, a local anaesthetic, is used to suppress airway reflexes and reduce the risk of laryngospasm during extubation. Its mechanism involves blocking sodium channels, thereby stabilizing the neuronal membrane and preventing the initiation and transmission of nerve impulses, thus effectively mitigate the hemodynamic and airway responses to extubation. 
Intervention  DEXMEDETOMIDINE NEBULISATION  Dexmedetomidine is a highly selective alpha 2-adrenoreceptor agonist, which possesses hypnotic, sedative, anxiolytic, sympatholytic, and analgesic properties without producing significant respiratory depression. Dexmedetomidine, with 8 times greater affinity than clonidine, decreases the sympathetic outflow and noradrenergic activity thereby counteracting the hemodynamic fluctuation occurring at the time of extubation. 
Comparator Agent  NORMAL SALINE NEBULISATION  Normal saline nebulisation is used as a control group to compare the efficacy of Dexmedetomidine and 2% Lidocaine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Written and valid consent
ASA I and II
Age 18 to 60 years
Patients undergoing surgery under General Anaesthesia
Duration less than 3 hours 
 
ExclusionCriteria 
Details  Patient refusal
Chronic smokers more than 20 pack years
Patients with compromised cardiopulmonary respiratory status requiring special anaesthetic
plan
Head and neck surgery
Any known allergy to the study drugs 
 
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 assess and compare cough response in different groups during extubation.  T0
Point at which sevoflurane is cut off
T1
Point where reversal agent is given
T2
2 mins after administration of reversal
TE
Point of extubation
T3
2 mins after extubation
T4
5 mins after extubation
T5
10 mins after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To assess & compare the hemodynamic changes during extubation  Point at which sevoflurane is cut off
Point at which reversal agent is given
2 mins after reversal
Point of extubation
2 mins after extubation
5 mins after extubation
10 mins after extubation 
To assess emergence agitation  Point at which sevoflurane is cut off
Point at which reversal agent is given
2 mins after reversal
Point of extubation
2 mins after extubation
5 mins after extubation
10 mins after extubation 
To assess any complications, post extubation like stridor due to laryngospasm or any other cause, vomiting, wheeze, desaturation, pulmonary edema  Point at which sevoflurane is cut off
Point at which reversal agent is given
2 mins after reversal
Point of extubation
2 mins after extubation
5 mins after extubation
10 mins after extubation 
Duration of recovery - the time between the point where sevoflurane is cut off & the point where extubation is done  Point at which sevoflurane is cut off
Point at which reversal agent is given
2 mins after reversal
Point of extubation
2 mins after extubation
5 mins after extubation
10 mins after extubation 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study is a randomised double blinded controlled study sone to assess to compare the effects of in-line nebulisation with dexmedetomidine vs 2% lidocaine prior to extubation on extubation response in patients undergoing surgery under general anaesthesia. The primary objective is to assess and compare cough response in different groups during extubation and the secondary outcomes are a) To assess and compare the hemodynamic changes during extubation, b) To assess emergence agitation c) To assess any complications, post extubation like stridor due to laryngospasm or any other cause, vomiting, wheeze, desaturation, pulmonary edema. d) Duration of recovery - the time between the point where sevoflurane is cut off and the point where extubation is done. 
Close