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CTRI Number  CTRI/2025/03/081938 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To check harshness in throat after using different things to inflate endotracheal cuff. 
Scientific Title of Study   To study the effect of cuff insufflation with lidocaine, saline or air on post operative sore throat during laparoscopic surgeries in steep Trendelenburg position 
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 Sarthak Misra 
Designation  Junior resident 
Affiliation  Indira Gandhi institute of medical sciences 
Address  Department of anaesthesiology and ccm 1st floor ward block, Igims

Patna
BIHAR
800014
India 
Phone  08210641979  
Fax    
Email  drsarthakmisra2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bibha Kumari 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of medical sciences 
Address  Department of anaesthesiology and ccm 1st floor ward block, Igims

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bibha Kumari 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of medical sciences 
Address  Department of anaesthesiology and ccm 1st floor ward block, Igims

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Patna, Bihar 800014 
 
Primary Sponsor  
Name  Dr Sarthak Misra 
Address  Indira Gandhi Institute of medical sciences, 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 
Dr Sarthak Misra  Indira Gandhi Institute of medical sciences  Neuro OT complex 1-12, Department of Anesthesia
Patna
BIHAR 		 08210641979

drsarthakmisra2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee, 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  cuff insufflation  cuff insufflation with air 8ml 
Intervention  Cuff insufflation  cuff insufflation with lidocaine 8ml and saline 8ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient of ASA 1, ASA 2 and ASA 3 physical status
Patients between 18-65 years of age of either sex
Patient with Mallampati Class I-II
Patients posted for major laparoscopic surgeries under General Anaesthesia in steep trendelberg position
•Patient willing to Participate.
 
 
ExclusionCriteria 
Details  Patient with Pregnancy, morbid obesity, and history of sore throat, asthma, COPD, psychiatric disorders and smokers.
Patient who required reintubation after extubation within 48hours.
Patient who had delayed emergence or transferred to ICU intubated after operation under General Anaesthesia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the tracheal tube cuff pressure after inflation with air, normal saline, or lignocaine at various time points during laparoscopic surgeries in the steep Trendelenburg position.  5 minutes, 30 minutes, 1 hour, 12 hours, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the severity of Postoperative airway complications like sore throat, & hoarseness at 2 hr, 12 hr & 24hr time intervals  2 hours, 12 hours, 24 hours 
 
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)   31/03/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsarthakmisra2021@gmail.com].

  6. For how long will this data be available start date provided 30-11-2025 and end date provided 30-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

 Nowadays, ultrasound is simple to obtain, it is unknown whether tracheal tube cuff pressure correlates with tracheal transverse diameter (TD) and tracheal tube cuff transverse diameter (CD). So this prospective randomized controlled trial is hypothesized to assess endotracheal tube cuff pressure after pneumoperitoneum, the severity of tracheal mucosal damage and postoperative airway complications when the tracheal tube cuff was inflated with room-temperature air, 2% lidocaine or NS and to investigate if TD and CD measured by ultrasound can be used to predict tracheal tube cuff pressure. 

 
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