| CTRI Number |
CTRI/2025/11/097398 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing drugs Amisulpride and Dexamethasone in reducing nausea and vomiting after surgery in high risk patients. |
|
Scientific Title of Study
|
Comparing the efficacy of intravenous Amisulpride and Dexamethasone in preventing postoperative nausea and vomiting in high risk patients : A randomized controlled double blind 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 Aryan Dimri |
| Designation |
Post graduate Resident |
| Affiliation |
All India Institute of Medical Sciences,Rishikesh |
| Address |
Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra Marg,Rishikesh
Dehradun
UTTARANCHAL
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7016400378 |
| Fax |
|
| Email |
aryandimri30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Rishikesh |
| Address |
Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra Marg,Rishikesh
Dehradun
UTTARANCHAL
249203
India
Phone
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Rishikesh |
| Address |
Department of Anaesthesia All India Institute of Medical Sciences, Veerbhadra Marg,Rishikesh
Dehradun
UTTARANCHAL
249203
India
Phone
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, AIIMS Rishikesh |
| Address |
Department of Anaesthesiology,Level 6, Virbhadra Road, Rishikesh, District: Dehradun, Pincode: 249203, Uttarakhand, 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 Aryan Dimri |
AIIMS Rishikesh |
Operating Room 2 to 16 ,Level 6, Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL |
7016400378
aryandimri30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh |
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 |
inj Dexamethasone 8mg |
Group D will receive inj dexamethasone 8 mg intravenously and will be wheeled into the operation theatre after 10 minutes. |
| Intervention |
inj. Amisulpride 5mg |
inj Amisulpride 5mg will be given 10 min prior to induction of anaesthesia to group A and patient will be monitored for adverse effect like QT prolongation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Apfel criteria of more than 2.
2) American society of anaesthesiologists (ASA) physical class I-II
3) Non-smoker
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal to participate in study
2) Any previous history of drug reaction to amisulpride
3) Patient with severe hepatic or renal dysfunction or cardiac dysfunction
4) Patient requiring orogastric /nasogastric tube in the post-operative period.
5) Patient with poorly controlled diabetes mellitus – HbA1c more than 9
6) Patient on medications which prolong QT interval.
7) Patient on other antipsychotic medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Postoperative Nausea and Vomiting (PONV) in 24 hrs of post operative period: In the ward, episodes of vomiting, retching will be recorded, and nausea score as per 11-point verbal rating scale from 0-10 with zero being no nausea and 10 being worst possible nausea and significant nausea defined as a score of 4 and above.
|
Above findings will be evaluated at 1st, 2nd, 6th, 12th and 24 hours of post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total dose of rescue anti emetic recorded in post operative period of 24 hours
2. Duration of PACU stay
3. Any amisulpride related adverse events in post operative period of 24 hours
|
total dose of rescue antiemetic (injection ondansetron) at the end of 24 hrs post op period.
Duration of pacu stay ( duration in post op till patient is shifted from pacu to ward)
adverse events will be followed up for at 1st , 2nd , 6th & 24th hours of post operative period. |
|
|
Target Sample Size
|
Total Sample Size="324"
Sample Size from India="324"
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)
|
24/11/2025 |
| 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="6"
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
|
Comparing the Efficacy of Intravenous Amisulpride and Dexamethasone in Preventing Postoperative Nausea and Vomiting in High Risk Patients A Randomized Controlled Double Blind Study. Postoperative nausea and vomiting is a common and distressing complication following general anesthesia with an incidence up to 80 percent in high risk patients. It can delay recovery and hospital discharge. Risk factors include female gender, non smoking status, previous history of PONV or motion sickness, and perioperative opioid use. Dexamethasone is widely used as a prophylactic antiemetic but may cause hyperglycemia especially in diabetic patients. Amisulpride, a dopamine D2 and D3 receptor antagonist, has shown efficacy in preventing PONV in recent studies with minimal adverse effects. Comparative data between amisulpride and dexamethasone are limited in the Indian population. This study aims to compare their efficacy in preventing PONV among high risk surgical patients.This is a randomized double blind controlled trial conducted at AIIMS Rishikesh. A total of 324 adult patients aged 18 to 65 years, ASA physical status I or II, with an Apfel score of more than two, will be included. Patients will be randomly allocated into two groups. Group A will receive intravenous amisulpride 5 milligrams ten minutes before induction of anesthesia. Group D will receive intravenous dexamethasone 8 milligrams ten minutes before induction. Standardized anesthesia and analgesia protocols will be followed. Blinding will be maintained for patients and outcome assessor. The primary outcome is the incidence of postoperative nausea and vomiting within 24 hours after surgery. Secondary outcomes include severity of nausea, requirement for rescue antiemetic medication, duration of stay in post anesthesia care unit, and adverse effects related to amisulpride. This study will evaluate and compare the effectiveness and safety of intravenous amisulpride and dexamethasone for the prevention of postoperative nausea and vomiting in high risk patients undergoing general anesthesia. |