| CTRI Number |
CTRI/2024/02/062477 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of injectable amisulpride and ondansetron medicine for reduction of nausea and vomiting after gynecological laparoscopic surgery operation. |
|
Scientific Title of Study
|
Comparison of intravenous amisulpride and ondansetron for prevention of postoperative nausea and vomiting after gynaecological laparoscopy: a randomized clinical 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 VELLORE SRIKANTH HAMSA |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anaesthesiology, Second floor Operation Theatre Complex Operation Theatre No 2, Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
8985681175 |
| Fax |
|
| Email |
hamsavs97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of anaesthesiology Second floor, Operation theatre Complex theatre no 2, Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anaesthesiology, Second floor, Operation Theatre Complex theatre no 2, Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur Seepat Road Lingiadih village Bilaspur Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Lingiadih village Seepat road Bilaspur |
| 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 |
| Vellore Srikanth Hamsa |
Apollo Hospitals Bilaspur |
Department of Anaesthesiology, Second floor, Operation theatre complex, theatre no 2, Seepat Road Lingiadih village
Bilaspur
CHHATTISGARH |
8985681175
hamsavs97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
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 |
amisulpride 5 mg diluted with 5 ml normal saline at the time of induction of anesthesia slowly over 2 minutes. Assessment period 24 hours |
| Comparator Agent |
Ondansetron |
ondansetron 4 mg diluted with 5 ml normal saline at the time of induction of anesthesia slowly over 2 minutes.
Assessment period 24 hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade I and II Scheduled for laparoscopic surgery under general anesthesia
|
|
| ExclusionCriteria |
| Details |
Allergy to any drug involved in the study
History of other antiemetic drug usage and motion sickness
Morbid obesity
Emergency surgery
History of alcohol opioid and drug abuse
Psychiatric and pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of nausea and vomiting |
assessment periods: 0–2 hr, 2–6 hr and 6–24 h after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue antiemetic and patients satisfaction score |
Assessment periods: 0–2 hr, 2–6 hr and 6–24 h after surgery. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/02/2024 |
| 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)
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvinit75@gmail.com].
- For how long will this data be available start date provided 01-11-2024 and end date provided 31-05-2025?
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
|
Postoperative nausea and vomiting are common and problematic after general anesthesia in laparoscopic surgery. The incidence of PONV in gynecological surgery occurs at a rate of 40 to 75% even as high as 90%. PONV is associated with female gender, previous PONV, motion sickness, smoke free status and opioid use. The use of intravenous amisulpride for prevention of PONV in gynecological laparoscopic surgeries has not been explored. Amisulpride is a selective antagonist of dopamine D2 and D3 receptors. Therefore, the present study aimed to probe and investigate the effectiveness of intravenous amisulpride and ondansetron for prevention of PONV in laparoscopic surgery. All selected patients will be randomized in to two groups (40 patients in each group) depending on the drug used. Group A- received intravenous amisulpride 5 mg diluted with 5 ml normal saline at the time of induction of anesthesia slowly over 2 minutes. Group O - received intravenous ondansetron 4 mg diluted with 5 ml normal saline at the time of induction of anesthesia slowly over 2 minutes. Primary outcome is incidence and severity of PONV experienced by each patient after surgery and recorded at following three assessment periods: 0-2 hr, 2-6 hr and 6-24 hr after surgery. Secondary outcome is requirement of rescue antiemetic at same time interval and patient satisfaction score after 24 hr after surgery. Statistical analysis will be done after completion of study. |