| CTRI Number |
CTRI/2024/04/065036 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 medicines- Amisulpride and Ondansetron to find out which is better for preventing Nausea and vomiting following Laparoscopic Gynaecological surgery. |
|
Scientific Title of Study
|
Comparison of Amisulpride and Ondansetron for the prevention of Postoperative Nausea and Vomiting in patients undergoing laparoscopic gynaecological surgeries |
| 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 Rupesh Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr.RML hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupesh Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr.RML hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupesh Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.RML Hospital |
| Address |
Department of Anaesthesia, ABVIMS and Dr.RML hospital, New Delhi
Central
DELHI
110001
India |
| Phone |
9460720444 |
| Fax |
|
| Email |
drrupesh.yadav98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, ABVIMS and Dr.RML Hospital, Baba Kharak Singh Road,type 3, Connaught place, New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS and Dr. RML hospital, Baba Kharak Singh Road, near Gurudwara Bangla Sahib,Type 3 Presidents estate, Connaught place, New Delhi-110001 |
| 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 |
| Rupesh Gopalakrishnan |
ABVIMS and Dr.Ram Manohar Lohia Hospital |
Room number.304, Department of Anaesthesia, ABVIMS and Dr.Ram Manohar Lohia Hospital,Baba Kharak Singh Marg, near Gurudwara Bangla Sahib, Connaught place,New Delhi- 110001
Central
DELHI |
8667373249
rupeshgopalakrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. RML Hospital New Delhi Ethics Committee |
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 |
Preoperatively just before induction of Anaesthesia,group A patients will be given a single dose of Amisulpride 5mg slow i.v. over 30 seconds.
|
| Comparator Agent |
Amisulpride and Ondansetron |
Preoperatively just before induction of Anaesthesia,group A patients will be given a single dose of Amisulpride 5mg i.v and group B patients will be given single dose of Ondansetron 4 mg i.v based on computer randomisation. Patient will be monitored for 24 hrs postoperatively and be compared based on PONV score. |
| Intervention |
Ondansetron |
Preoperatively just before induction of anaesthesia, group B will be given single dose of Ondansetron 4mg i.v. over 30 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Females undergoing Laparoscopic Gynaecological surgery. |
|
| ExclusionCriteria |
| Details |
Patients having history of motion sickness or past history of PONV.
Smokers.
History of allergy to the drug to be given.
Patients with liver disease.
Patients receiving chemotherapy or radiotherapy within the past four weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative nausea and vomiting in the first 24 hours following surgery measured using postoperative Nausea score, Postoperative vomiting score and PONV score |
From end of surgery to 24 hrs after end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Requirement of rescue anti-emetic in both groups.
2) Incidence of adverse effects like headache, dizziness, dizziness etc |
From administration of drug to 24 hrs after end of surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/04/2024 |
| 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)
|
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 randomised Comparative study to compare the effect of Amisulpride and Ondansetron for prevention of Postoperative Nausea and Vomiting in adult patients undergoing Laparoscopic Gynaecological surgery to be conducted in ABVIMS and Dr.RML Hospital,New Delhi -110001. Sample size-200 (100 in each group) The primary objective is to compare the effectiveness of Amisulpride and Ondansetron in preventing PONV in first 24 hrs following surgery. The secondary objectives are to assess the requirement of rescue anti-emetic and to assess the incidence of adverse effects in both groups.
|