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CTRI Number  CTRI/2025/09/094680 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the effectiveness and performance of two airway devices i gel and baska mask in laparoscopic appendicectomy under general anaesthesia 
Scientific Title of Study   COMPARISON OF OLP (OROPHARYNGEAL LEAK PRESSURE) AND PERFORMANCE CHARACTERISTICS OF I-GEL AND BASKA MASK IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY UNDER GENERAL ANAESTHESIA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHAH ZALAK SHEETALKUMAR 
Designation  resident doctor (MD anaesthesiology) 
Affiliation  GMERS medical college and hospital 
Address  6th floor,department of anaesthesiology,GMERS medical college and hospital,gotri,vadodara

Vadodara
GUJARAT
390021
India 
Phone  9512898025  
Fax    
Email  kaushalshah1311@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VISHAL SHRIMALI 
Designation  ASSOCIATE PROFFESSOR (MD Anaesthesiology) 
Affiliation  GMERS medical college and hospital 
Address  6th floor,department of anaesthesiology,GMERS medical college and hospital,gotri,vadodara

Vadodara
GUJARAT
390021
India 
Phone  9825792920  
Fax    
Email  drvishalshrimali@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHAH ZALAK SHEETALKUMAR 
Designation  resident doctor (MD anaesthesiology) 
Affiliation  GMERS medical college and hospital 
Address  6th floor,department of anaesthesiology,GMERS medical college and hospital,gotri,vadodara

Vadodara
GUJARAT
390021
India 
Phone  9512898025  
Fax    
Email  kaushalshah1311@gmail.com  
 
Source of Monetary or Material Support  
GMERS Hospital,gotri,vadodara,Gujarat,India-390021 
 
Primary Sponsor  
Name  GMERS HOSPITAL 
Address  Old TB campus,gotri main road,gotri,vadodara 
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 ZALAK SHAH  GMERS hospital  ANAESTHESIA DEPARTMENT,6TH FLOOR,HOSPITAL BUILDING,OLD TB CAMPUS,GOTRI MAIN ROAD,GOTRI,VADODARA -390021
Vadodara
GUJARAT 		 9512898025

kaushalshah1311@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC GMERS MEDICAL COLLEGE AND HOSPITAL ,GOTRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  PERFORMANCE CHARACTERISTICS AND OLP (OROPHARYNGEAL LEAK PRESSURE)  After insertion of baska mask,Correct placement will be confirmed by observing the chest rise, bilateral air entry with stethoscope and the square waveform in the capnography. Muscle relaxant Injection Atracurium (0.5 mg/kg) will be given to all the patient after confirming the placement of BASKA MASK.measure the duration of insertion,attempts of insertion,and measure OLP AND observe any maneuver to maintain airway patency. 
Intervention  PERFORMANCE CHARACTERISTICS AND OLP (OROPHARYNGEAL LEAK PRESSURE) OG IGEL  After insertion of igel Correct placement will be confirmed by observing the chest rise, bilateral air entry with stethoscope and the square waveform in the capnography. Muscle relaxant Injection Atracurium (0.5 mg/kg) will be given to all the patient after confirming the placement of SGDs. Appropriate size of gastric tube will be inserted via gastric port given in the device.measure duration of insertion,attempt of insertion and Oropharyngeal leak pressure of igel and observe any maneuver to maintain airway patency. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA GRADE 1 AND 2, BMI MORE THAN 19 AND LESS THAN 30
MOUTH OPENING MORE THAN OR EQUAL TO 2.5 FINGERS
PATIENT IS WILLING TO PARTICIPATE AND GIVE CONSENT. 
 
ExclusionCriteria 
Details  PATEINT WHO DID NOT COMPLY TO MINIMUM 8 HOURS OF FASTING,WITH DIFFICULT AIRWAY,WITH ACTIVE UPPER RESPIRATORY TRACT INFECTION,WITH HIGH RISK OF ASPIRATION 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
DIFFERENCE OF OLP IN IGEL AND BASKA MASK AFTER INSERTION IN PATIENTS UNDERGOING LAPAROSCOPIC APPENDICECTOMY SURGERY   DIFFERENCE OF OLP IN IGEL AND BASKA MASK MEASURE AT 1 MIN,5 MIN AFTER INSERTION AND AFTER CREATIMG A PNEUMOPERITONEUM  
 
Secondary Outcome  
Outcome  TimePoints 
1. ASSESMENT OF FIRST ATTEMPT SUCCESS RATE
2.NUMBER OF ATTEMPTS
3.TIME TO INSERT THE BOTH SUPRAGLOTTIC AIRWAY AND COMPARE THEM
4.NUMBER OF AIRWAY MANIPULATION REQUIRED TO ACHIEVE ADAQUATE VENTILATION
5. OBSERVATION OF POST OP COMPLICATION 		 1.SUPRAGLOTTIC DEVICE INSERTED IN SINGLE ATTEMPT OR NOT.
2.NUMBER OF ATTEMPTS REQUIRED FOR SUCCESSFUL INSERTION.
3.TIME OF INSERTION-AFTER STARTING TO INSERT TO SHOW CAPNOGRAPH AND CHEST RISE SEEN.
4.FOR PROPER VENTILATION ANY AIRWAY MANIPULATION DONE OR NOT.
5. OBSERVE ANY POST OP COMPLICATION LIKE SORE THROAT,BLEEDING,DYSPNEA,LARYNGOSPASM 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   24/09/2025 
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="1"
Months="0"
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   the study is being conducted to compare the effectiveness of two suoraglottic airway devices,the baska mask and the igel,in adult patients undergoing elective laparoscopic appendicectomy under general anaesthesia.the main aim is to rpvides better seal,measured by oropharyngeal leak pressure,and to assess their clinical performance.
after approval from the institutional human ethics committee,written informed consent will be obtained from eligible patients aged 18-60 years,with ASA  1 and 2 and BMI 19-30 kg/m2.particioants will be randomly allocated to either the baska mask group or the i gel group using envelope method.
all patients will undergo standard preanaesthetic assessment and fasting protocols.intraoperative monitoring will include ecg,non invasive blood pressure,pulse oximetry and capnography.patient induced with routine GA protocols.then igel or baska mask inserted and correct placement will be confirmed by b/l air entry checked and capnograph show square wave.and oropharyngeal leak pressure measure at 1 mins,5 mins and after creating pneumoperitonium.by taking spontenous ventilation,pressure adjusted valve closed up to 40 and then monitored plateu pressure.the value of plateu pressure > 10 sec consider as orophryngeal leak pressure.
a total 50 patients (25 each group) will be recruited based on sample size calculation for adaquate statistical power.this propspective randomised,open label study will be conducted in department of anaesthesiology,GMERS gotri,vadodara,over a period of one year.
the primary outcome is oropharyngeal leak pressure.secondary outcomes includes first attempt success rate,number of attempts,insertion time,need for airway manipulations,post operative any complications.
 
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