| CTRI Number |
CTRI/2025/09/094050 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
propofol infusion and antiemetic requirement |
|
Scientific Title of Study
|
Comparison of two different doses of intra operative propofol infusion on post operative rescue antiemetic requiremnt after inhalational 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 |
Diana John |
| Designation |
Post graduate resident |
| Affiliation |
Maulana azad medical college |
| Address |
Department of anaesthesia, maulana azad medical college,new delhi
Central
DELHI
110002
India |
| Phone |
7356904980 |
| Fax |
|
| Email |
annadianajohn98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mona Arya |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of anaesthesia,maulana azad medical college ,new delhi
Central
DELHI
110002
India |
| Phone |
9968604412 |
| Fax |
|
| Email |
monaarya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mona Arya |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of anaesthesia,maulana azad medical college ,new delhi
Central
DELHI
110002
India |
| Phone |
9968604412 |
| Fax |
|
| Email |
monaarya@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college |
|
|
Primary Sponsor
|
| Name |
Diana John |
| Address |
post graduate resident, department of anaesthesia, maulana azad medical college ,delhi |
| 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 |
| Diana John |
Maulana azad medical college and associated hospitals |
department of anaesthesiology, BL taneja block ,third floor,2,bahadur shah zafar marg,new delhi,110002
Central
DELHI |
7356904980
annadianajohn98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana azad medical college and associated hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
propofol infusion at the rate of 25microgram per kg per minute |
patients recieving propofol infusion at the rate of 25 microgram per kg per minute |
| Intervention |
propofol infusion at the rate of 50 microgram per kg per minute |
patients recieving propofol infusion at the rate of 50 microgram per kg per minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 to 3
BMI 18 to 30 |
|
| ExclusionCriteria |
| Details |
pregnant and lactating patients
cardiac, neuro,bariatric surgeries
surgical duration more than 6 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of patients requiring rescue anti emetics in first four hours for PONV |
proportion of patients requiring rescue anti emetics in first four hours for PONV |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of patients having ponv in first 24 hrs post op |
first 24 hours |
| total requirement of rescue antiemetics in 24 hrs post op |
24 hrs post op |
| time to discharge from pacu as per modified aldret score more than nine |
nil
|
|
|
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)
|
22/09/2025 |
| 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 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
|
Intra operatively patients will be administered with propofol infusion at the rate of 25 microgram per kg per minute in one group and 50 microgram per kg per minute in the next group and patients will be asessed for requirement of rescue antiemetics for postoperative nausea and vomoting in the first four hours also as in intervals of zero 4 8 12 and 24 hours using a 3point scale .where zero is no nausea or vomiting, one is only nausea, two is vomiting with or without nausea. |