| CTRI Number |
CTRI/2022/10/046220 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between propofol and dexamethasone for preventing postoperative nausea and vomiting after ENT surgeries. |
|
Scientific Title of Study
|
To compare the effectiveness of propofol versus dexamethasone for preventing postoperative nausea and vomiting after ear, nose, and throat surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathvika Pati |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College hospital and research centre |
| Address |
Department of Anaesthesiology, Dr. D.Y Patil medical college hospital and research centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7795446246 |
| Fax |
|
| Email |
sathvikareddy009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
| Address |
Department of Anaesthesiology, Dr. D.Y Patil medical college hospital and research centre,
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
| Address |
Department of Anaesthesia Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA 411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy; hitech ot 5th floor, Dr DY patil medical college hospital and research centre, pimpri, pune, Maharashtra, pin code- 411018 |
|
|
Primary Sponsor
|
| Name |
Dr sathvika Pati |
| Address |
Dr. D.Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Sant Tukaram Nagar Pimpri Pune |
| 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 |
| Dr Sathvika Pati |
Dr. D.Y. Patil Medical College Hospital and Research Centre,Pimpri |
High tech OT complex, 5th floor, Dr. D.Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune MAHARASHTRA
Pune
MAHARASHTRA |
7795446246
sathvikareddy009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee Dr. D.Y. Patil Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous dexamethasone 8mg single dose |
Intravenous dexamethasone 8mg single dose given at the end of surgery for preventing postoperative nausea and vomiting |
| Comparator Agent |
Intravenous propofol 0.5mg/kg single dose |
Propofol 0.5mg/kg single dose given intravenously at the end of surgery for preventing postoperative nausea and vomiting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in age group of 18 to 60 years Patients with ASA I and II
Hemodynamic stable patients
Patients posted for ear, nose and throat surgery under general anaesthesia Patients willing to give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with previous history of nausea or vomiting.
2) Gastroesophageal reflux disease.
3) Patients with known allergy to study drugs.
4) Obese patient
5) Patients with ASA>II
6) Lack of patient consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of propofol and dexamethasone for preventing postoperative nausea and vomiting. |
Immediate postoperative period,
After 30minutes, 1hour, 6hrs, 12hrs and 24hrs after giving study drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe any side effects |
First 24hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized, prospective, comparative, double blinded, observational study where in intravenous propofol and intravenous dexamethasone are compared for preventing postoperative nausea and vomiting after ear, nose and throat surgery. |