| CTRI Number |
CTRI/2026/04/109429 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare and determine the best time to insert tube over the breathing passage after starting anaesthesia with propofol medicine in patients undergoing surgery |
|
Scientific Title of Study
|
A Randomised Controlled Study to Determine the Appropriate Time for Placement of LMA R SupremeTM Supraglottic Airway Device with Propofol Induction. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhakti Trivedi |
| Designation |
Professor and Head , Division of Clinical Anaesthesia , ACTREC |
| Affiliation |
ACTREC |
| Address |
Department of Anaesthesia, Critical Care and Pain, RRS Building 7th Floor , ACTREC,Plot No. 1& 2, Sector 22,Kharghar, Navi Mumbai - 410210, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
02227405000 |
| Fax |
|
| Email |
bhaktiamit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhakti Trivedi |
| Designation |
Professor and Head , Division of Clinical Anaesthesia , ACTREC |
| Affiliation |
ACTREC |
| Address |
Department of Anaesthesia, Critical Care and Pain, RRS Building 7th Floor , ACTREC,Plot No. 1& 2, Sector 22,Kharghar, Navi Mumbai - 410210, Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
02227405000 |
| Fax |
|
| Email |
bhaktiamit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smarasmita Sen |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital , Parel East , Mumbai , Maharashtra-400012, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
smarasmita16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai, 400012, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel , Mumbai, Maharashtra 400012 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Bhakti Trivedi |
Tata Memorial Centre |
OT Complex, 7th floor , RRS Building, ACTREC ,Plot no 1 and 2 , Sector 22 , Kharghar , Navi Mumbai-410210,Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA |
9820333472
bhaktiamit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre- Institutional Ethics Committee –III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of different time points of LMA insertion |
LMA insertion after induction with propofol at time points of 30/60/90 seconds |
| Intervention |
LMA insertion after induction with propofol |
To determine the appropriate time for LMA insertion after induction of anaesthesia with propofol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients more than or equal to18 years of age with an American Society of Anaesthesiologists ASA I - III scheduled for elective surgeries under general anaesthesia for which LMA is an appropriate choice for airway management |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate
2. Patient at risk of aspiration like patients who are inadequately fasting, patients with intestinal obstruction/perforation.
3. Patients undergoing emergency surgery
4. Patient with restricted mouth opening
5. Patients with upper airway obstructions such as airway tumor, abscess, edema and/or hematoma
6. Patient with disrupted upper airway, facial or upper airway trauma, airway burns
7. Patients who are morbidly obese(BMI more than 40kg/m²)
8. Pregnant patients
9. Patients with poor lung compliance
10. Patients in whom iv Propofol is to be avoided
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the appropriate time for LMA® SupremeTM supraglottic airway device insertion after induction of anaesthesia with IV Propofol. |
30/60/90 seconds after induction with propofol as per the group allocated to the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Determine the incidence of improper placement of LMA at all the three time intervals.
2. Determine the extent of adverse response to airway manipulation like coughing, gagging, laryngospasm and patient movements at all the three time intervals of LMA insertion. |
30/60/90 seconds after induction with propofol as per the group allocated to the patient |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
11/05/2026 |
| 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)
|
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
|
LMA® SupremeTM supraglottic airway device is a device inserted through the mouth and is used to deliver oxygen to patients under general anaesthesia Before inserting the LMA patients are usually administered a medicine called Propofol to make them unconscious However there is no clarity regarding the best time of LMA insertion after the administration of Propofol Also it is not very clear whether the time interval between when a person becomes unconscious to when the LMA is inserted affects the ease of placement of LMA If it is placed too early or too late after administering Propofol it can cause problems like gagging coughing or difficulty in placing the device
This study looks at the best time to easily insert LMA® SupremeTM type of supraglottic airway device after administering Propofol Finding the best time for placement can make surgeries safer and more comfortable for patients
People undergoing surgery which will need placement of LMA® SupremeTM type of supraglottic airway device will be randomly assigned to three different groups Each group will have the LMA inserted at a specific time after receiving Propofol The doctors will then observe and make a note of the parameters used to assess the ease of LMA insertion
The results will help doctors to understand the best time to insert the supraglottic airway device after giving Propofol This will help to improve safety reduce complications and make anaesthesia smoother for patients
|