| CTRI Number |
CTRI/2026/01/101554 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO COMPARE THE EFFECTS OF SPLIT DOSE OF DEXAMETHASONE GIVEN PREOPERATIVELY AND POSTOPERATIVELY VERSUS SINGLE DOSE OF DEXAMETHASONE GIVEN PREOPERATIVELY ON POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS POSTED FOR LAPAROSCOPIC GYNAECOLOGIACAL SURGERIES LASTING 2-3 HOURS |
|
Scientific Title of Study
|
Comparison of perioperative Dexamethasone split between two doses versus preoperative single dose for postoperative nausea and vomiting in Laparoscopic Gynecological Surgeries: A prospective randomized double-blind 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 |
Ananta Srilalita Bulusu |
| Designation |
junior resident |
| Affiliation |
Karnataka medical college and research institute |
| Address |
Room number 206, Anesthesia department, Karnataka medical college, Vidya Nagar, Hubballi
Room number 206, Anesthesia department, Karnataka medical college, Vidya Nagar, Hubballi
Bangalore
KARNATAKA
580021
India |
| Phone |
7348841250 |
| Fax |
|
| Email |
lalitabulusu98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini H R |
| Designation |
Associate professor |
| Affiliation |
Karnataka medical college and research institute |
| Address |
Karnataka medical college and research institute, Department of Anesthesiology, Room no 206 JP Building division, Hubballi, India
Karnataka medical college and research institute, Department of Anesthesiology, Room no 206 JP Building division, Hubballi, India
Dharwad
KARNATAKA
580022
India |
| Phone |
7348841250 |
| Fax |
|
| Email |
ashvenki.hubli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananta Srilalita Bulusu |
| Designation |
junior resident |
| Affiliation |
Karnataka medical college and research institute |
| Address |
Karnataka medical college and research institute, Department of Anesthesiology, Room no 206 JP Building division, Hubballi, India
Karnataka medical college and research institute, Department of Anesthesiology, Room no 206 JP Building division, Hubballi, India
Dharwad
KARNATAKA
580022
India |
| Phone |
7348841250 |
| Fax |
|
| Email |
lalitabulusu98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ananta Srilalita Bulusu |
| Address |
Karnataka medical college and research institute, Department of Anesthesiology, Room no 206 JP Building division, Hubballi, India- 580022
|
| 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 |
| Ananta Srilalita Bulusu |
Karnataka medical college and research institute |
Karnataka medical college and research institute, Department of Anesthesiology, Room no 206 JP Building division, Hubballi, India- 580022
Dharwad
KARNATAKA |
7348841250
lalitabulusu98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE, HUBBALLI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ADMINISTERATION OF 4MG DEXAMETHASONE BEFORE INDUCTION |
65 PATIENTS WILL RECEIVE 4MG BOLUS DOSE OF DEXAMETHASONE AT THE TIME OF INDUCTION |
| Comparator Agent |
SPLIT DOSE OF DEXAMETHASONE |
65 PATIENTS WILL RECEIVE 4MG DEXAMETHASONE AT THE TIME OF INDUCTION AND 4MG DEXAMETHASONE AFTER EXTUBATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA CLASS 1 AND 2 |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WHO REFUSE TO GIVE CONSENT
2.PATIENTS WHO HAVE HISTORY OF ALLERGY TO DEXAMETHASONE
3.PREGNANT PATIENTS
4.PATIENTS WITH DIABETES MELLITUS
5.RHEUMATOID IMMUNE SYSTEM DISEASES
6.LIVER AND KIDNEY FAILURE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECTS OF SPLIT DOSE OF DEXAMETHASONE GIVEN PREOPERATIVELY AND POSTOPERATIVELY VERSUS SINGLE DOSE OF DEXAMETHASONE GIVEN PREOPERATIVELY ON POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS POSTED FOR LAPAROSCOPIC GYNAECOLOGIACAL SURGERIES LASTING 2-3 HOURS |
TO ASSESS POSTOPERATIVE NAUSEA VOMITING AT 0, 6, 12, 18, 24, 48, 72 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of dexamethasone on blood sugar levels |
24 hours after the surgery |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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
|
Postoperative nausea and vomiting is common in laparoscopic gynaecologial surgeries. The purpose of the study to compare the effects of dexamethasone split dose ,i.e 4mg at the time of induction and 4mg after extubation versus single dose i.e 8mg of Dexamethasone at the time of induction. |