| CTRI Number |
CTRI/2025/12/099662 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Medicines Palonosetron and Ondansetron to Prevent Vomiting After Laparoscopic Surgery in Women |
|
Scientific Title of Study
|
Comparison of Palonosetron with Ondansetron for prevention of Postoperative Nausea and Vomiting in Female patients undergoing Laparoscopic Surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhumitha V V |
| Designation |
Post graduate Student |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8675673454 |
| Fax |
|
| Email |
madhu2107752@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi- 110029, India |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, Pin code- 110029, India |
| 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 |
| Dr Madhumitha V V |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology and Intensive Care, Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
DELHI |
86756 73454
madhu2107752@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhaman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj.Ondansetron 0.1 mg/kg iv |
Female Patients undergoing Laparoscopic Abdominal surgeries will be given Inj Ondansetron 0.1 mg/kg iv before induction and assessed for PONV |
| Intervention |
Inj.Palonosetron 1mcg/kg iv |
Female patients undergoing Laparoscopic abdominal surgeries are given Inj Palonosetron 1mcg/kg iv before induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patients undergoing Laparoscopic Abdominal surgeries of ASA I and II |
|
| ExclusionCriteria |
| Details |
1. BMI more than or equal to 30kg / m2
2. Patients with a known history of Gastric Esophageal Reflux Disease
3.Allergic to Study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the incidence of postoperative nausea and vomiting with the use of Palonosetron and Ondansetron in first 24 hrs following Laparoscopic surgeries in female patients using PONV scoring system |
0 hrs, 2 hrs, 6 hrs , 12 hrs, 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the need for rescue antiemetics
2. To evaluate Patient Satisfaction score regarding PONV management in both groups |
0 hrs , 2 hrs, 6 hrs, 12 hrs, 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
01/01/2026 |
| 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="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
|
Postoperative nausea and vomiting (PONV) remain common after laparoscopic surgery, especially among female patients. Palonosetron, a second-generation 5-HT3 antagonist with a long half-life, may provide better PONV prophylaxis compared to ondansetron. This prospective randomized interventional study will compare palonosetron (1 mcg/kg IV) and ondansetron (0.1 mg/kg IV) administered before induction of anesthesia in 156 female patients undergoing laparoscopic surgery. Primary outcome is incidence of PONV in 0–24 hours postoperatively. Secondary outcomes include rescue antiemetic requirement, patient satisfaction, adverse effects, and hemodynamic changes. |