| CTRI Number |
CTRI/2026/01/101354 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two airway devices (Proseal laryngeal mask airway and endotracheal tube) in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
A Comparative study between Proseal LMA Versus Endotracheal tube among Anaesthetized adult patients undergoing Elective Laparoscopic Cholecystectomy procedures: A Prospective Observational Study |
| 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 Kiran A V |
| Designation |
Associate Professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Associate Professor Department of Anaesthesiology Mandya institute of medical sciences,Mandya,Karnataka 571401
Mandya
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
mimsmandya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran A V |
| Designation |
Associate Professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Associate Professor Department of Anaesthesiology Mandya institute of medical sciences,Mandya,Karnataka 571401
Mandya
KARNATAKA
571401
India |
| Phone |
8867917802 |
| Fax |
|
| Email |
mimsmandya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lohith M |
| Designation |
Post graduate student |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology Mandya institute of medical sciences,Mandya,Karnataka 571401
3rd Cross,RP road ,Opposite to KEB office,Nanjangud,Mysore, Karnataka 571301
Mandya
KARNATAKA
571401
India |
| Phone |
9148043173 |
| Fax |
|
| Email |
lohithrohith1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya institute of medical sciences ,Karnataka571401 |
|
|
Primary Sponsor
|
| Name |
Dr Kiran A V |
| Address |
Associate professor Department of Anaesthesiology Mandya institute of medical sciences 571401 |
| Type of Sponsor |
Other [Associate professor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Lohith M |
Department of Anaesthesiology Mandya institute of medical sciences |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lohith M |
Mandya institute of medical sciences, Mandya |
Department of Anaesthesiology Mandya institute of medical sciences,571401
Mandya
KARNATAKA |
9148043173
lohithrohith1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committe Mandya institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ENDOTRACHEAL TUBE |
ENDOTRACHEAL TUBE OF APPROPRIATE SIZE |
| Intervention |
PROSEAL LMA |
PROSEAL LMA OF APPROPRIATE SIZE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent
Patients with ASA 1 And ASA 2
Patients undergoing Laparoscopic Cholecystectomy under GA with either proseal LMA or endotracheal tube
Mallampati 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with Anticipated Difficult airway
H/O OSA
Upper respiratoery tract infections
Patients with incresed risk of Aspiration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemodynamic parameters (Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) following airway insertion using Proseal laryngeal mask airway compared with endotracheal tube. |
Baseline(before airway insertion), immediately after insertion, and at 1, 3 and 5 minutes after airway insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Proseal LMA Vs Endotracheal tube with respect to side effects |
Post operatively every 3hrly upro 24hrs. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
22/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is designed to compare the hemodynamic stress response and ease of insertion between ProSeal laryngeal mask airway and endotracheal tube in adult patients undergoing elective surgery under general anaesthesia. Participants will be randomly allocated to receive airway management using either ProSeal laryngeal mask airway or endotracheal tube. Hemodynamic parameters such as heart rate and blood pressure will be recorded at baseline and at predefined time intervals following airway insertion. Ease of insertion will be assessed using standard clinical criteria. The outcomes will be compared between the two groups. |