| CTRI Number |
CTRI/2025/12/099205 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the drugs (amisulpride and palonosetron) for prevention of nausea and vomiting in patients for removal of uterus |
|
Scientific Title of Study
|
Antiemetic efficacy of prophylactic amisulpride versus palonosetron in patients undergoing Total Laparoscopic Hysterectomy: A randomized, double-blinded trial |
| 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 Anand Soliya |
| Designation |
Junior Resident |
| Affiliation |
IMS BHU |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7987369345 |
| Fax |
|
| Email |
anandsoliya78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Soliya |
| Designation |
Junior Resident |
| Affiliation |
IMS BHU |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7987369345 |
| Fax |
|
| Email |
anandsoliya78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Soliya |
| Designation |
Junior Resident |
| Affiliation |
IMS BHU |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7987369345 |
| Fax |
|
| Email |
anandsoliya78@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir Sunderlal Hospital, IMS, BHU |
| Address |
IMS, BHU, Varanasi-221005 |
| 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 Atul Kumar Singh |
Sir Sunderlal Hospital, Institute of Medical Sciences |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
08317010317
atulksingh84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amisulpride |
Group A: Amisulpride 10 mg intravenously over a period of 1 minute after induction of general anaesthesia for prevention of postoperative nausea and vomiting in patients undergoing total laparoscopic hysterectomy |
| Comparator Agent |
Palonosetron |
Group P: Palonosetron 0.075 mg intravenously over a period of 1 minute after induction of general anaesthesia for prevention of postoperative nausea and vomiting in patients undergoing total laparoscopic hysterectomy |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) Female patients aged between 40-60 years
2) ASA PS I and II
3) Patients scheduled for total laparoscopic hysterectomy |
|
| ExclusionCriteria |
| Details |
1) Patients having history of CAD, COPD, DM
2) Patients in which laparoscopic surgery gets converted to open surgery
3) Patients requiring postoperative ventilation |
|
|
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 |
| comparison of antiemetic efficacy of amisulpride with that of palonosetron in the prevention of PONV |
The participants will be watch for symptoms like nausea and/or vomiting after the completion of surgery in the post-operative period at 0(baseline),1,2,3,4,5,6,9,12,15,18,24,30,36,42,48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Requirement of rescue antiemetic
2) Effect of duration of surgery on PONV |
0,1,2,3,4,5,6,12,18,24,30,36,42,48 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
26/12/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aim: To compare the antiemetic efficacy of amisulpride with that of palonosetron for prevention of postoperative nausea and vomiting in patients undergoing total laparoscopic hysterectomy. Methods: Study will be conducted after ethics committee approval in female patients of ASA PS I and II undergoing total laparoscopic hysterectomy. Patients (total 140) will be randomly assigned into two groups: Group A: amisulpride 10 mg i.v. after induction of general anaesthesia Group P: receiving palonosetron 0.075 mg i.v. after induction of general anaesthesia PONV will be assessed at specified time intervals in the postoperative period upto 48 hours after surgery. Need of rescue antiemetic requirement and the effect of duration of surgery on PONV will also be noted. Primary objective: Prevention of PONV in postoperative period Secondary objective: 1) Need of rescue antiemetic. 2) Effect of duration of surgery on PONV
Study period: 6 months |