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CTRI Number  CTRI/2025/12/099682 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the advantages and disadvantages of various Supraglottic airway devices 
Scientific Title of Study   Comparative Evaluation of Laryngeal Mask Airway(LMA) ProSeal LMA, I-gel, Baska Mask and LMA Protector Supraglottic Airway Devices in Adult Laparoscopic Surgeries: A Randomized Controlled Trial 
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 CHAITANYA KAMAT 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical college Belagavi 
Address  Department of anaesthesiology, 2nd floor, KLEs Dr Prabhakar Kore hospital and medical research centre, Belagavi

Belgaum
KARNATAKA
590001
India 
Phone  8150038305  
Fax    
Email  drchaitanya12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr CHAITANYA KAMAT 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical college Belagavi 
Address  Department of anaesthesiology, 2nd floor, KLEs Dr Prabhakar Kore hospital and medical research centre, Belagavi

Belgaum
KARNATAKA
590001
India 
Phone  8150038305  
Fax    
Email  drchaitanya12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr CHAITANYA KAMAT 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical college Belagavi 
Address  Department of anaesthesiology, 2nd floor, KLEs Dr Prabhakar Kore hospital and medical research centre, Belagavi

Belgaum
KARNATAKA
590001
India 
Phone  8150038305  
Fax    
Email  drchaitanya12@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  CHAITANYA A KAMAT 
Address  #B 901 UR CASA( Katti Apartment) Sadashiv Nagar Belagavi 
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 
CHAITANYA A KAMAT  DR.Prabhakar kore charitable hospital and research centre   department of anaesthesiology second floor DR.Prabhakar kore charitable hospital and research centre nehru nagar belagavi 590010 Belgaum KARNATAKA
Belgaum
KARNATAKA 
8150038305

drchaitanya12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jnmc institutional ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  no comrbidites 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insertion of I-gel  Oropharyngeal leak pressure, Ease of insertion and Insertion time will be noted and is compared with other supraglottic airway devices 
Intervention  Insertion of Proseal LMA  Oropharyngeal leak pressure, Ease of insertion and Insertion time will be noted and is compared with other supraglottic airway devices 
Comparator Agent  Nil  will be compared among those 4 devices 
Intervention  Use of Baska mask  Oropharyngeal leak pressure, Ease of insertion and Insertion time will be noted and is compared with other supraglottic airway devices 
Intervention  Use of LMA protector  Oropharyngeal leak pressure, Ease of insertion and Insertion time will be noted and is compared with other supraglottic airway devices 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults undergoing elective Laparoscopic surgeries under general anaesthesia aged 18-60 years.
Surgeries lasting up to 120 min or less.
American Society of Anaesthesiologist- ASA grade I and II
Mallampati grade 1 and II  
 
ExclusionCriteria 
Details  -Upper airway obstruction.
-Potential difficult intubation.
-High risk of aspiration.  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Oropharyngeal leak pressure of Proseal laryngeal mask airway vs Igel vs Baska mask vs LMA protector in patients posted for elective laparoscopic surgeries.  immediately after insertion of device 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Ease of insertion & Insertion time of Proseal laryngeal mask airway vs Igel vs Baska mask vs LMA protector.   During securing of airway with LMA 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   14/01/2026 
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 Applicable 
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  

Consent for anaesthesia and participation in the study will be taken. On the day of surgery nil by mouth status of 8 hrs will be confirmed and intravenous cannula will be secured. Aspiration prophylaxis will be given with Inj pantoprazole 40mg and Inj ondansetron 8mg.

  Group A- LMA Proseal will be used, Group B – I-gel , Group C – Baska mask and  Group-D – LMA Protector will be used in the operating room, standard monitors will be attached. All the patients will be initially pre - medicated with intravenous Inj. Glycopyrrolate at 0.005mg/kg, Inj. Midazolam at 0.05mg/kg and Inj. Fentanyl at 2mcg/kg. Pre-oxygenation with 100% oxygen will be given for 3 minutes. Anaesthesia will be induced with Inj Propofol 2mg/kg and neuromuscular blockade by Inj Atracurium 0.5mg/kg. Airway device of appropriate size will be inserted in accordance with manufacturer’s recommendation.

Oropharyngeal leak pressure (OLP) will be determined after 5min of insertion of device and 5 min of pneumoperitoneum.

  The expiratory valve of the circle system will be closed at a fixed gas flow of 6 Litres per minute and recording the airway pressure at which gas leak occurs by detection of an audible noise by using stethoscope placed just lateral to thyroid cartilage. The ease of insertion will be defined as:

· Very easy : absolutely no resistance

· Easy: no resistance to insertion in the single manoeuvre.

· Difficult: resistances to insertion in the single manoeuvre

· Very difficult: more than one manoeuvre was required for the correct placement of the device. If an effective airway could not be achieved, the device wil be removed and failure of insertion will be recorded and endotracheal intubation will be done.

 The duration of insertion will be defined as the time taken from the prepared LMA touching the incisors of the teeth to the successful placement of the device confirmed by square wave capnography, bilateral equal air entry and bilateral chest rise.

       Patients will be ventilated at an inspired tidal volume of 6- 8 ml/kg, respiratory rate of 12-14 breaths/minute and an inspiratory: expiratory ratio of 1:2. Anaesthesia will be maintained with 1:1 oxygen-nitrous oxide mixture, Isoflurane (0.6-1%) and inj. Atracurium 0.15 mg/kg (IV) boluses.

 Once the procedure is done, the neuromuscular blockade will be reversed with intravenous inj. Glycopyrrolate of dose 0.001mg/kg and inj. Neostigmine of dose 0.05mg/kg. After the return of protective airway reflexes, regain of consciousness, the airway device will be removed and ventilated with facemask for 5 min.

 
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