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CTRI Number  CTRI/2022/10/046164 [Registered on: 04/10/2022] Trial Registered Prospectively
Last Modified On: 03/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare Air vs 2% lignocaine as Endotracheal cuff Insufflation medium and its effect on Post-operative sore throat. 
Scientific Title of Study   Intraoperative monitoring of endotracheal cuff pressure and volume on insufflation with air vs 2% lignocaine and its implication on post operative sore throat: a comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jethroben KevinR 
Designation  Post-Graduate 
Affiliation  ESIC Medical college and PGIMSR, K.K Nagar,Chennai-600078 
Address  Department of Anaesthesiology, ESIC Medical College , K.K Nagar, Chennai-600078

Thiruvallur
TAMIL NADU
600078
India 
Phone  8056034998  
Fax    
Email  jethrobenkevin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDeepakR 
Designation  Associate professor  
Affiliation  ESIC Medical college and PGIMSR, K.K Nagar,Chennai-600078 
Address  Department of Anaesthesiology, ESIC Medical College, K.K Nagar, Chennai-600078

Thiruvallur
TAMIL NADU
600078
India 
Phone  9482049960  
Fax    
Email  deepakrbangalore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jethroben KevinR 
Designation  Post-Graduate 
Affiliation  ESIC Medical college and PGIMSR, K.K Nagar,Chennai-600078 
Address  Department of Anaesthesiology, ESIC Medical College, K.K Nagar, Chennai-600078

Thiruvallur
TAMIL NADU
600053
India 
Phone  8056034998  
Fax    
Email  jethrobenkevin@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, ESIC Medical College, K.K Nagar, Chennai-600078 
 
Primary Sponsor  
Name  ESIC Medical College and PGIMSR 
Address  ESIC Medical College and PGIMSR K.K Nagar,Chennai-600078 
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 
DrJethroben KevinR  ESIC Medical College and PGIMSR  ESIC Medical College and PGIMSR K.K Nagar Chennai
Chennai
TAMIL NADU 		 8056034998

jethrobenkevin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% Lignocaine solution  To insufflate Endotracheal Cuff with 2% lignocaine Solution and monitor Cuff pressure,Cuff volume,Heart rate,Blood pressure, Oxygen saturation. 
Comparator Agent  AIR  To insufflate Endotracheal Cuff with Air and monitor Cuff pressure,Cuff volume,Heart rate,Blood pressure, Oxygen saturation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  atient with written informed consent
● 18-60 yrs. of Age
● ASA physical status I-II
● Elective surgery
● Supine Position
● Under General Anaesthesia more than 120mins with Endotracheal Intubation.
 
 
ExclusionCriteria 
Details  Patient refusal
• Procedures involving soft tissue around airway
• ASA III or above
• History of known allergic to local anaesthetics
• History of recent upper respiratory tract infection
• History of present COVID-19 infection
• Laryngeal disease/surgery
• H/O smoking
• Those requiring insertion of nasogastric tube.
• Those requiring more than 1 attempt to achieve tracheal intubation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cuff Pressure using AG-Cufffill monitor in CmH2O  At start of surgery,every 15min till end of suregry, and before removing endotracheal tube(end of surgery). 
 
Secondary Outcome  
Outcome  TimePoints 
Variation in Cuff volume  At start of surgery and end of surgery 
Heart rate , Blood pressure, Oxygen saturation using standard monitors  At start of surgery,every 15min till end of suregry, and before removing endotracheal tube(end of surgery). 
Incidence of Post operative sore throat  After surgery at 30 min,12 hour,24hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   17/10/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

This research study will be conducted in patients planned for elective surgery under General anaesthesia. This is a comparative study of Cuff pressure monitoring when ETT cuff is insufflated with Air vs 2%Lignocaine.Multiple parameters will be monitored. Previous such studies indicated that 2% Lignocaine is better in terms of variation in cuff pressure and it’s effect on Post-Operative sore throat.

 
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