| CTRI Number |
CTRI/2026/01/102066 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two sets of medicines to see which one works better in preventing nausea and vomiting caused by oxytocin during surgery. One group receives ondansetron with dexamethasone, and the other group receives metoclopramide with dexamethasone. |
|
Scientific Title of Study
|
Comparison of ondansetron with dexamethasone versus metoclopramide with dexamethasone for intraoperative oxytocin induced nausea and vomiting 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 |
Dr Saundarya R |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anaesthesiology, 2nd floor OT complex, Shri Sathya Sai Medical College and Research Intstitute Ammapettai, Chengalpet district,Tamil Nadu , India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7338520220 |
| Fax |
|
| Email |
saundaryaraja55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Prasad. T |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anaesthesiology, 2nd floor OT complex, Shri Sathya Sai Medical College and Research Intstitute Ammapettai, Chengalpet district,Tamil Nadu , India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7338520220 |
| Fax |
|
| Email |
saundaryaraja55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saundarya R |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anaesthesiology, 2nd floor OT complex, Shri Sathya Sai Medical College and Research Intstitute Ammapettai, Chengalpet district,Tamil Nadu , India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7338520220 |
| Fax |
|
| Email |
saundaryaraja55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Saundarya R |
| Address |
Womens Hostel, Shri Sathya Sai Medical College and Research Intstitute Ammapettai, Chengalpet district,Tamil Nadu , India
Kancheepuram
TAMIL NADU-603108
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saundarya R |
Shri Sathya Sai Medical College Hospital and Research Institute |
Department of Anaesthesiology, 2nd floor OT complex, Shri Sathya Sai Medical College and Research Intstitute Ammapettai, Chengalpet district,Tamil Nadu , India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
7338520220
saundaryaraja55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1and 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ondansetron with dexamethasone versus Metoclopramide with dexamethasone |
Oxytocin will be given intravenously after delivery/manipulation. Group O will receive Ondansetron 4 mg + Dexamethasone 8 mg, and Group M will receive Metoclopramide 10 mg + Dexamethasone 8 mg, which will be administered intravenously 15 minutes before the end of surgery. |
| Intervention |
Ondansetron with dexamethasone versus Metoclopramide with dexamethasone |
Oxytocin will be given intravenously after delivery/manipulation. Group O will receive Ondansetron 4 mg + Dexamethasone 8 mg, and Group M will receive Metoclopramide 10 mg + Dexamethasone 8 mg, which will be administered intravenously 15 minutes before the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female patients under reproductive age group between 18 and 40 years.
Patient under ASA physical status I or II.
Patients undergoing elective cesaerean or gynaecological surgery under spinal anaesthesia.
Patients receiving exclusively oxytocin intraoperatively.
|
|
| ExclusionCriteria |
| Details |
Patients receiving Carboprost and Methergine.
Patients with history of motion sickness or postoperative nausea and vomiting.
Patients with prior antiemetic use within 24 hours.
Patients with known allergy to study drugs.
Patients with BMI more than 30 kg per m².
Procedures that get converted to general anaesthesia.
Patients with pre existing GI, neurological, or psychiatric disorders.
|
|
|
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 |
| Incidence of intraoperative vomiting after oxytocin administration, from administration until the end of surgery, comparing ondansetron and dexamethasone versus metoclopramide and dexamethasone. |
30 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the severity & frequency of vomiting episodes in both groups
To determine the need for rescue antiemetics in both treatment arms
To identify any adverse drug reactions associated with the use of either combination therapy
|
30 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/02/2026 |
| 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="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 prospective randomized comparative study is designed to evaluate the effectiveness of ondansetron with dexamethasone versus metoclopramide with dexamethasone in preventing intraoperative nausea and vomiting induced by oxytocin during elective caesarean section under spinal anaesthesia. Eligible parturients will be randomly allocated into two groups, Group O will receive ondansetron with dexamethasone, and Group M will receive metoclopramide with dexamethasone. The primary outcome is the incidence of intraoperative nausea and vomiting from the time of oxytocin administration until the end of surgery. Secondary outcomes include severity of nausea and vomiting, requirement for rescue antiemetics, and patient satisfaction. As all drugs are already approved and widely used, the study is classified as a Phase 4 trial, aiming to provide comparative efficacy data to guide optimal prophylaxis of oxytocin induced intraoperative nausea and vomiting. |