| CTRI Number |
CTRI/2025/08/093415 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study On Olanzapine and Amisulpride for reducing Nausea and Vomiting After Laparoscopic Gynecology Surgery |
|
Scientific Title of Study
|
To Study the effect of olanzapine and amisulpride in post operative nausea and vomiting in
laparoscopic gynecological surgeries -A randomized double-blind study |
| Trial Acronym |
GYNOVA Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NithishT |
| Designation |
Post Graduate |
| Affiliation |
IMS & SUM Hospital |
| Address |
Department of Anaesthesiology and Critical Care Medicine
IMS AND SUM Hospital
Khordha
ORISSA
751003
India |
| Phone |
8072246307 |
| Fax |
|
| Email |
nithishthangaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusmita Patro |
| Designation |
Professor |
| Affiliation |
IMS & SUM Hospital |
| Address |
Department of Anaesthesiology and Critical Care Medicine
IMS AND SUM Hospital
Khordha
ORISSA
751003
India |
| Phone |
8072246307 |
| Fax |
|
| Email |
dr.madhu.patro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NithishT |
| Designation |
Post Graduate |
| Affiliation |
IMS & SUM Hospital |
| Address |
Department of Anaesthesiology and Critical Care Medicine
IMS AND SUM Hospital
Khordha
ORISSA
751003
India |
| Phone |
8072246307 |
| Fax |
|
| Email |
nithishthangaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM hospital, SOA UNIVERSITY Bhubaneswar Odisha 751003 |
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
K8, Kalinganagar, Bhubaneswar, Odisha,751003 |
| Type of Sponsor |
Private 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 |
| Dr NithishT |
IMS AND SUM HOSPITAL |
Department of Anaesthesiology and Critical Care Medicine,
K8 Kalinganagar, Bhubaneswar
Khordha
ORISSA |
08072246307
nithishthangaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amisulpride |
Inj amisulpride 5 mg slow iv 30 mins before induction and at the end of Surgery patients will be extubated and monitored for postoperative nausea and vomiting from 0 hours and Initial 2 hours Monitoring every 30 minutes Then 2hrs,4hrs,6hrs,8hrs,12hrs,18hrs,24hrs.
Rescue antiemetic Inj dexamethasone 8 mg will be given if a patient develops postoperative nausea and vomiting irrespective of the drug given and the total duration of 24 hours patients will be followed up post operatively. |
| Intervention |
Olanzapine |
Tab olanzapine 10mg P/O 90 mins before inductionat the end of Surgery patients will be extubated and monitored for postoperative nausea and vomiting from 0 hours and Initial 2 hours Monitoring every 30 minutes Then 2hrs,4hrs,6hrs,8hrs,12hrs,18hrs,24hrs.
Rescue antiemetic Inj dexamethasone 8 mg will be given if a patient develops postoperative nausea and vomiting irrespective of the drug given the total duration of 24 hours patients will be followed up post operatively. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients between age 20 to 50 years posted for elective
laparoscopic gynecological surgeries requiring general anesthesia will be included |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate in the study
2.Pregnant or lactating female
3.Patient having cardiovascular/neurological condition
4.Patients on Antipsychotic medication
5.History of allergy to study drug |
|
|
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 |
| To monitor postoperative nausea and vomiting for 24 hrs |
Incidence of postoperative nausea and vomiting will be assessed at the following time points :0.5hr,1hr,1.30hr,2hr,4hr,6hr,8hr,12hr,18hr and 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of rescue antiemetic
2.Total dose of rescue antiemetic.
3.Side effects if any. |
From end of surgery to 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
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)
|
01/09/2025 |
| 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="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
|
1.This prospective randomized double blinded comparative study will be conducted at our institution over a period of 1.5 years. 2.In this study 110 ASA grade I and II patients between age 20 to 50 years posted for elective laparoscopic gynecological surgeries requiring general anesthesia will be included. 3.After taking written informed consent, patients will be randomized into two groups (n= 110)by computer generated random number table. 4.All patients will be thoroughly examined pre- operatively which includes history, general physical examination, and checking the vital parameters, and systemic examination and ASA grading of patients. 5.All the patients will be kept empty stomach for at least 6 hours before the procedure. 6.All the routine monitors will be attached and the preoperative baseline parameters (noninvasive blood pressure, (NIBP), pulse rate (PR), and saturation (SPO2) )will be noted.An 18-Gauge IV cannula will be secured all patients irrespective of the group they belong to. 7.Patients in group A will receive Inj amisulpride 5 mg slow iv 30 mins before induction . Patients in group B will receive T.olanzapine 10mg P/O 90 mins before induction. 8.Patients will be given following premedication drugs, Inj glycopyrrolate 0.2mg iv ,Inj Midazolam 1mg iv, Inj fentanyl(2mcg/kg) and induced with Inj propofol(1.5mg/kg) iv and Inj vecuronium (0.1mg/kg) iv as muscle relaxant initially and followed by 0.02mg as maintenance. 9.At the end of Surgery patients will be extubated and monitored for postoperative nausea and vomiting from ‘0’ hours . 10.Initial 2 hours: Monitoring every 30 minutes ,Then 2hrs,4hrs,6hrs,8hrs,12hrs,18hrs,24hrs. 11.Rescue antiemetic Inj dexamethasone 8 mg will be given if a patient develops postoperative nausea and vomiting irrespective of the drug given. |