| CTRI Number |
CTRI/2024/03/063683 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of preoperative Olanzapine on the incidence of postoperative nausea and vomiting |
|
Scientific Title of Study
|
Effectiveness of preoperative Olanzapine versus Placebo, as an add on drug, on the incidence of postoperative nausea and vomiting in laparoscopic gynecological surgeries: a stratified randomised control 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 Nirmala Phobba |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of Anesthesia, OT Complex, 1st floor, hospital building, AIIMS BHUBANESWAR,
Khordha,
ORISSA
751019
INDIA
Khordha
ORISSA
751019
India |
| Phone |
9886000593 |
| Fax |
|
| Email |
nirmalaphobba1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanta Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of Anesthesia, 4th floor, room no- 409, hospital building, AIIMS BHUBANESWAR,
Khordha,
ORISSA
Khordha
ORISSA
751019
India |
| Phone |
9312677007 |
| Fax |
|
| Email |
anaes_prasanta@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmala Phobba |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of Anesthesia, OT Complex, 1st floor, hospital building, AIIMS BHUBANESWAR,
Khordha,
ORISSA
751019
INDIA
Khordha
ORISSA
751019
India |
| Phone |
9886000593 |
| Fax |
|
| Email |
nirmalaphobba1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical care, AIIMS Bhubaneswar, Sijua, Patrapada, KHORDA,
ORISSA,
751019 |
|
|
Primary Sponsor
|
| Name |
Dr Prasanta Kumar Das |
| Address |
AIIMS BHUBANESWAR, Sijua, Patrapada, Khordha, Odisha- 751019 |
| 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 Prasanta Kumar Das |
AIIMS BHUBANESWAR |
OT Complex, Department of Anesthesiology and Critical Care,
Khordha
ORISSA |
9312677007
anaes_prasanta@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N709||Salpingitis and oophoritis, unspecified, (2) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Olanzapine |
GROUP A will be given one tablet of 10mg oral olanzapine in the preoperative area, one hour before surgery and will be assessed for incidence of postoperative nausea and vomiting for 24 hours after surgery |
| Comparator Agent |
Placebo |
GROUP B will be given one tablet placebo orally in the preoperative area, one hour before surgery and will be assessed for incidence of postoperative nausea and vomiting for 24 hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Gynecological patients undergoing laparoscopic surgeries
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
no consent, allergic to study drugs, renal and hepatic failure, on antiemetic and antipsychotic medications, prolonged qt interval, history of obstructive sleep apnea |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of PONV in first 24 hours after surgery between two groups |
To compare the incidence of PONV in first 24 hours after surgery between two groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity of nausea and vomting by 4- point severity scale |
over 24 hours |
| requirement of rescue antiemetic (inj.Metoclopramide 10mg IV) |
12 hours |
| Quality of recovery(QoR - 15) |
over 24 hours |
| Side effects of Olanzapine |
over 24 hours |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Postoperative nausea and vomiting (PONV) is the most distressing event after laparoscopic gynecological surgeries. There have been studies showing the incidence is still nearly 40% even after using dual prophylactic measures. Olanzapine has been effective in reducing PONV in chemotherapy induced nausea and vomiting. In this study we hypothesize that administering preoperative oral Olanzapine in addition to intraoperative ondansetron and dexamethasone would further reduce the incidence of PONV. |