| 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
|
|
|
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
|
|
|
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
|
|
|
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. |