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CTRI Number  CTRI/2024/06/069570 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This study evaluates the effectiveness of three insertion methods of supraglottic airway device= I -Gel in adult patients undergoing laparoscopic cholecystectomy under general anesthesia (GA). This would help the anesthesiologist choose best technique for airway management. 
Scientific Title of Study   Comparison of three insertion techniques of I-GEL placement in laparoscopic surgery: standard, laterally from right angle of mouth and a unique technique with vibratory movements. 
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. Divesh Arora 
Designation  Director and HOD 
Affiliation  Asian Hospital Faridabad 
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A , badkal flyover road , Faridabad - 121002

Faridabad
HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divesh Arora 
Designation  Director and HOD 
Affiliation  Asian Hospital Faridabad 
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A , badkal flyover road , Faridabad - 121002


HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divesh Arora 
Designation  Director and HOD 
Affiliation  Asian Hospital Faridabad 
Address  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A , badkal flyover road , Faridabad - 121002


HARYANA
121002
India 
Phone  9650099113  
Fax    
Email  drdivesh@gmail.com  
 
Source of Monetary or Material Support  
Asian Institute of medical sciences, Sector 21 A , badkal flyover road , Faridabad - 121002  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Divesh Arora  Asian Hospital Faridabad  Department of Anesthesia and OT services, 3rd floor, Asian Institute of medical sciences, Sector 21 A , badkal flyover road , Faridabad - 121002
Faridabad
HARYANA 		 09650099113

drdivesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ASIAN HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insertion technique for I -Gel insertion.  We will compare three insertion techniques of I GEL insertion in patients undergoing Laparoscopic cholecystectomy under GA for the time period required for insertion and will monitor till the surgery lasts. 
Comparator Agent  Other insertion techniques for I -Gel insertion.  We will compare the other insertion techniques of I GEL insertion in patients undergoing Laparoscopic cholecystectomy under GA for the time period required for insertion and will monitor till the surgery lasts. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All patients undergoing laparoscopic cholecystectomy
ASA I II
 
 
ExclusionCriteria 
Details  ASA PS 3 and 4 
 
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 
We will record the mean insertion time at first attempt of I -gel insertion.  Time period will be recorded as the time from opening the jaw till the insertion is complete. This will be de done after induction of anesthesia at 0 hr. 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of insertion, First attempt & Overall success rate of I gel insertion.



Ease of placement of nasogastric tube.

Intraoperative & postoperative complications like blood staining of I-gel, sore throat, bronchospasm.

 		 after surgery 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   16/07/2024 
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)  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   I-gel is a supraglottic airway device used for securing airway. There is a standard technique of insertion as recommended by manufacturers. This technique is not successful in some patients. This is a clinical research topic for evaluating three different techniques of I gel insertion in patients undergoing laparoscopic cholecystectomy under GA to find out the best technique available, so as to be incorporated in daily practice. 
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