| CTRI Number |
CTRI/2025/08/092407 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare i.v promethazine and i.v amisulpride for the treatment of post operative nausea and vomiting in female patients after receiving general anaesthesia |
|
Scientific Title of Study
|
Comparison of intravenous amisulpride with promethazine for the treatment of postoperative nausea and vomiting in female patients after general anaesthesia: A double-blind randomised 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 Bharti Goel |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room no 315 third floor department of Anaesthesiology and Intensive Care BL taneja block Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8851683377 |
| Fax |
|
| Email |
bhartigoel1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhyanti kerai |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 413 4 th floor department of Anaesthesiology and Intensive Care BL Taneja Block Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Goel |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 315 third floor department of Anaesthesiology and Intensive Care BL taneja block Maulana Azad Medical college
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated lok Nayak Hospital, Bahadur Shah zafar marg new Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology 3rd floor room no.308, BL Taneja block ,MAMC campus |
| Type of Sponsor |
Government medical college |
|
|
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 Bharti goel |
Lok Nayak Hospital |
OT block 1,2,3 new operation theatre block department of Anaesthesiology
Central
DELHI |
8851683377
bhartigoel1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee , Maulana Azad Medical College |
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 |
| Intervention |
Intravenous amisulpride |
One group of female patients having postoperative nausea and vomiting will receive i.v amisulpride 10 mg |
| Comparator Agent |
Intravenous promethazine |
Another group p of female patients experiencing post operative nausea vomiting will receive 6.25 mg promethazine iv |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patients undergoing elective surgical procedures under general anaesthesia who are ASA 1,2 or 3 |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Patients undergoing total intravenous anaesthesia
Significant ongoing vestibular disease or dizziness
Known prolactin dependant tumours or pheochromocytoma
Those with clinically signicant cardiac arrhythmias or long QT syndrome
Patients with substance abuse
History of psychiatric illness epilepsy or Parkinson’s disease
Documented allergy to amisulpride or any other dopamine antagonists drugs |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with complete response to treatment dose of amisulpride or promethazine. The complete response will be defined as :cessation of nausea , retching or vomiting with no recurrence and no rescue medications in the 4 hrs after administration, excluding any emesis events in first 15 minutes
|
4 hrs after shifting the patient to PACU
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean verbal descriptive scale (VDS) score for nausea |
At 5 minute interval upto 30 minutes and at 2,6,12,24 hrs after administration of study drugs |
| Number of episodes of emesis after administration of study drugs |
|
| Mean time to achieve complete response |
|
| Total no. Of doses of rescue antiemetics after surgery |
At 24 hrs |
| Any side effects of study drugs |
|
| Mean postoperative quality recovery -15 score |
At 24 hrs after surgery |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhartigoel1999@gmail.com].
- For how long will this data be available start date provided 30-06-2027 and end date provided 30-06-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The title of my thesis is comparison of intravenous amisulpride with promethazine for the treatment of postoperative nausea and vomiting in female patients after general anaesthesia. It is a randomized double-blind randomized study . Sample size is 224 . Patients who will be experiencing nausea vomiting even after giving intraoperatively ondansreron 4 mg will be divided into two groups randomly by sealed envelopes. One group will be given intravenous amisulpride and another group will be given intravenous promethazine. The response of both drugs in terms of episodes of emesis and nausea using VDS score will be noted. Any side effects of the drugs will be recorded too |