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CTRI Number  CTRI/2023/03/050634 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 12/03/2023
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 study to compare between two different routes of a drug called lignocaine in smooth post operative recovery after general anaesthesia. 
Scientific Title of Study   A comparative study between intravenous and subglottic instillation of lignocaine for blunting of stress response to tracheal extubation after general anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tuba Tufail 
Designation  PG Resident, M.D. Anaesthesiology 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology, First Floor, Ward Block, IGIMS
Bailey Road
Patna
BIHAR
800014
India 
Phone  8677817051  
Fax    
Email  tubatufail@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mumtaz Hussain  
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology, First Floor, ward Block, IGIMS
Bailey Road
Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Tuba Tufail 
Designation  PG Resident, M.D. Anaesthesiology 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology, First Floor, Ward Block, IGIMS
Bailey Road
Patna
BIHAR
800014
India 
Phone  8677817051  
Fax    
Email  tubatufail@hotmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences  
 
Primary Sponsor  
Name  Tuba Tufail 
Address  Department of Anaesthesiology, First Floor, Ward Block, IGIMS, Patna, Bihar- 800014 
Type of Sponsor  Other [Self] 
 
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 
Tuba Tufail  Indira Gandhi Institute of Medical sciences  Department of Anaesthesiology First Floor, near OT complex, IGIMS, Patna
Patna
BIHAR 		 8677817051

tubatufail@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee, IGIMS  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 
Comparator Agent  Intravenous Injection of Lignocaine (Group B).  Similarly Group B will receive 1.5mg/kg body weight of 2% intravenous lignocaine and an equal volume of normal saline will be administered via the subglottic port of endotracheal tube to ensure blinding. after 3 minutes extubation will be done. 
Intervention  Subglottic instillation of Lignocaine (Group A).  At the conclusion of the surgery residual neuromuscular blockade will be reversed with injection Glycopyrrolate(6mcg/kg) and injection Neostigmine (0.05mg/kg). Three minutes before extubation Group A will be administered 1.5mg/kg body weight of 2% lignocaine via subglottic port of special endotracheal tube (e.g. TUORen Supra/subglottic endotracheal tube). And an equal volume of normal saline will be given intravenously to avoid bias and to ensure blinding, followed by extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of ASA 1 and 2 physical status.
2. Patients between 16 to 60 years of age of either sex.
3. Patients able to comprehend and willing to participate.
4. Patients scheduled for elective surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Patients refusal to participate.
2. Patients with known contraindications or sensitivity to the study drug.
3. Patients with pregnancy, morbid obesity and history of sore throat.
4. Patients with requirement of postoperative ventilation. 
 
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 
Changes in Haemodynamic parameters namely Hear Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP).  Before Induction, at the time of administration of study drug, just before extubation then 1, 3, 5 and 10 minutes post extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Cough, sore throat, Laryngospasm.  Till 2 hours Post extubation. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tubatufail@hotmail.com].

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 31-03-2029?
    Response (Others) -  5 YEARS.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is a prospective double blinded trial to compare the efficacy of two different routes of the drug Lignocaine in blunting the stress response after tracheal extubation in patients undergoing general anaesthesia.  
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