| CTRI Number |
CTRI/2024/04/065000 [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
|
A Randomised Comparision of amisulpride with dexamethasone and ondansetron with dexamethasone in preventing postoperative nausea and vomiting in adult patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of amisulpride with dexamethasone and ondansetron with dexamethasone for prevention of postoperative nausea and vomiting in adult patients undergoing laparoscopic cholecystectomy: A Randomised Comparative 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 |
GAGAN S |
| Designation |
PG ANAESTHESIA |
| Affiliation |
Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia, Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi- 110001
Department of Anaesthesia, Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi- 110001
Central
DELHI
11001
India |
| Phone |
7829810896 |
| Fax |
|
| Email |
gaganmadhugiri2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Kachru |
| Designation |
Director Professor |
| Affiliation |
Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia, Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi- 110001
Central
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Kachru |
| Designation |
Director Professor |
| Affiliation |
Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia, Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi- 110001
DELHI
110001
India |
| Phone |
9810488435 |
| Fax |
|
| Email |
nishakachru@yahoo.co.uk |
|
|
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 |
Department of Anaesthesia, ABVIMS and Dr RML Hospital, 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 |
| GAGAN S |
Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
Room no 301, Department of Anaesthesia, PGI Building
Central
DELHI |
7829810896
gaganmadhugiri2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ABVIMS, Dr RML HOSPITAL, NEW DELHI |
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 |
AMISULPRIDE WITH DEXAMETHASONE AND ONDANSETRON WITH DEXAMETHSAONE |
Just after the induction of anaesthesia Group A patients will be given a single dose of Amisulpride 5mg IV+ Dexamethasone 4mg IV and Group B will be given single dose of Ondansetron 4mg IV+ Dexamethasone 4mg IV based on computer randomisation |
| Intervention |
AMISULSPRIDE WITH DEXAMETHASONE AND ONDANSETRON WITH DEXAMETHASONE |
Just after the induction of anaesthesia Group A patients will be given a single dose of Amisulpride 5mg IV+ Dexamethasone 4mg IV and Group B will be given single dose of Ondansetron 4mg IV+ Dexamethasone 4mg IV based on computer randomisation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Laparoscopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
Surgery lasting longer than 4 hours.
Patients receiving chemotherapy or radiotherapy within the past four weeks.
Use of any drugs with emetic or antiemetic action within 24 hours prior to surgery.
Pregnant females.
Patients with liver /kidney diseases.
|
|
|
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 |
| To compare amisulpride with dexamethasone and ondansetron with dexamethasone in the prevention of postoperative nausea and vomiting and in adult patients undergoing laparoscopic cholecystectomy using PONV score |
From the end of surgery to next 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Timing and total requirement of rescue antiemetic.
2. Satisfaction of patient
3. Occurrence of adverse effects, like headache, dizziness, drowsiness, pain at the site of injection etc.
|
From the end of surgery to next 24 hours |
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="208"
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)
|
12/04/2024 |
| 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 with dexamethasone and Ondansetron with dexamethasone for prevention of Postoperative Nausea and Vomiting in adult patients undergoing Laparoscopic cholecystectomy to be conducted in ABVIMS and Dr.RML Hospital,New Delhi -110001. Sample size-208 (104 in each group) The primary objective is to compare the effectiveness of Amisulpride with dexamethasone and Ondansetron with dexamethasone in preventing PONV in first 24 hrs following surgery. The secondary objectives are to assess the requirement of rescue anti-emetic, to assess the patient satisfaction and the incidence of adverse effects in both groups. |