| CTRI Number |
CTRI/2025/09/095118 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| 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
|
Comparing two medicines, amisulpride and palonosetron, to see which better prevents nausea and vomiting in patients after laparoscopic gallbladder removal. |
|
Scientific Title of Study
|
To compare efficacy of prevention of post operative nausea and vomiting between amisulpride and palonosetron in patients undergoing laparoscopic cholecystectomy. |
| 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 Saloni Das |
| Designation |
PG Resident |
| Affiliation |
IMS & SUM Hospital |
| Address |
PG Resident, Department of Anesthesiology, Institute of Medical Sciences and SUM Hospital(IMS), K8 Kalinga Nagar, Bhubaneswar, Odisha – 751029
Khordha
ORISSA
751029
India |
| Phone |
9330220563 |
| Fax |
|
| Email |
salony1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sulochana Dash |
| Designation |
Professor |
| Affiliation |
IMS & SUM Hospital |
| Address |
Professor, Department of Anesthesiology, Institute of Medical Sciences and SUM Hospital(IMS), K8 Kalinga Nagar, Bhubaneswar, Odisha – 751029
Khordha
ORISSA
751029
India |
| Phone |
9566841303 |
| Fax |
|
| Email |
dr.silu76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sulochana Dash |
| Designation |
Professor |
| Affiliation |
IMS & SUM Hospital |
| Address |
Professor, Department of Anesthesiology, Institute of Medical Sciences and SUM Hospital(IMS), K8 Kalinga Nagar, Bhubaneswar, Odisha – 751029
Khordha
ORISSA
751029
India |
| Phone |
9566841303 |
| Fax |
|
| Email |
dr.silu76@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Saloni Das |
| Address |
Kalinganagar Bhubaneswar Odisha 751029
|
| 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 Sulochana Dash |
IMS and SUM Hospital |
Department of Anesthesiology, IMS and SUM Hospital, Kalinga Nagar, Bhubaneswar – 751029
Khordha
ORISSA |
9566841303
dr.silu76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS & SUM Hospital |
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 |
Amisulpride |
Intravenous Amisulpride 10 mg, given as a slow IV injection at induction of anesthesia in patients undergoing elective laparoscopic cholecystectomy. |
| Comparator Agent |
Palonosetron |
Intravenous Palonosetron 75 mcg, given as an IV injection at induction of anesthesia in patients undergoing elective laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults of either sex ASA Physical Status I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they refuse consent OR belong to ASA physical status class III or IV OR are undergoing emergency laparoscopic surgery OR are smokers or alcoholics OR are pregnant or lactating OR have a history of postoperative nausea/vomiting or motion sickness OR are allergic to amisulpride or palonosetron OR have significant liver or renal disease OR are already on antiemetics, steroids, or psychomimetic drugs preoperatively OR if the surgery duration is greter than or equal to 3 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 |
1. To compare the incidence of nausea, vomiting and retching during post-operative 24 hrs in patients undergoing laparoscopic cholecystectomy.
2. To assess the severity of nausea and vomiting as recorded by PONV score.
3. The number and timing of doses of rescue antiemetic used during post op 24 hrs
|
10 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare:
1. patient satisfaction score and
2. adverse effects related to study drugs.
|
10 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
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="0"
Months="10"
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
|
This is a prospective randomized double blind comparative study in ASA I and II patients aged 18 years or older undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of 244 patients will be randomized into two groups by block randomization. Group AMP will receive intravenous amisulpride 10 mg and Group PLS will receive intravenous palonosetron 75 mcg at induction of anesthesia. Standardized anesthetic technique will be followed for all patients. Postoperative data on nausea, vomiting and retching will be collected at 0 to 2 hours in the recovery room and from 2 to 24 hours in the ward. Rescue antiemetics will be given if PONV score is more than one. Adverse effects related to study drugs and patient satisfaction will also be recorded. Patients converted to open surgery will be withdrawn from the study. |