| CTRI Number |
CTRI/2024/10/075539 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs for the prevention of nausea and vomiting after uterus removal surgery |
|
Scientific Title of Study
|
Comparison of Amisulpride versus Dexamethasone for prevention of PONV after laparoscopy assisted vaginal hysterectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Deepak |
| Designation |
DNB Postgraduate |
| Affiliation |
Kovai Medical Center and Hospital, Coimbatore |
| Address |
Department of Anaesthesia,
Kovai Medical Center and Hospital,
99, Avanashi Road,
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9039791690 |
| Fax |
|
| Email |
aditya.deepak64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumar Durairaju |
| Designation |
Consultant Anaesthetitst |
| Affiliation |
Kovai Medical Center and Hospital, Coimbatore |
| Address |
Department of Anaesthesia,
Kovai Medical Center and Hospital,
99, Avanashi Road,
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9003313627 |
| Fax |
|
| Email |
arunpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Deepak |
| Designation |
DNB Postgraduate |
| Affiliation |
Kovai Medical Center and Hospital, Coimbatore |
| Address |
Department of Anaesthesia,
Kovai Medical Center and Hospital,
99, Avanashi Road,
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9039791690 |
| Fax |
|
| Email |
aditya.deepak64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kovai Medical Center and Hospital, 99, Avanashi Road, Coimbatore 641014 |
|
|
Primary Sponsor
|
| Name |
Dr Aditya Deepak |
| Address |
DNB Anaesthesia Postgraduate,
Kovai Medical Center and Hospital, 99, Avanashi Road, Coimbatore 641014 |
| 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 Aditya Deepak DNB Anaesthesia |
Kovai Medical Center and Hospital |
Department of Anaesthesia,
OT Complex 2,
99, Avanashi Road,
Coimbatore 641014
Coimbatore
TAMIL NADU |
9039791690
aditya.deepak64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, (2) ICD-10 Condition: N819||Female genital prolapse, unspecified, (3) ICD-10 Condition: N926||Irregular menstruation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amisulpride |
One dose of the antiemetic Amisulpride 5mg for each participant in the study group |
| Comparator Agent |
Dexamethasone |
One dose of the antiemetic Dexamethasone 4mg to each participant in the control group |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Elective Laparoscopy Assisted Vaginal Hyseterectomy procedures of less than 4 hours duration
ASA 1 to 3
Weight 40 to 90 kg |
|
| ExclusionCriteria |
| Details |
Allergy to dexamethasone or amisulpride
History of motion sickness or previous PONV
Having nausea, vomiting or antiemetic medication in the 24 hours before surgery |
|
|
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 |
| Postoperative nausea or vomiting |
From extubation to next morning 9 am |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Use of rescue antiemetic |
From extubation to next morning 9 am |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="0"
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 study is for DNB Anaesthesia Thesis submission. It compares our current practice of giving one dose of Dexamethasone antiemetic for LAVH surgery with the newer antiemetic Amisulpride, which is already an established antiemetic in general use for chemotherapy induced nausea and vomiting. We will monitor for its efficacy in the perioperative setting and give rescue antiemetics if needed. We will also monitor for any side effects and treat them appropriately. |