A study to compare palonosetron with ondansetron for prevention of postoperative nausea vomiting (PONV) following gynaecological surgeries.

A randomized double-blind study to compare palonosetron with ondansetron for prevention of postoperative nausea vomiting (PONV) following gynaecological abdominal surgeries.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/03/012655

Enrollment

130

Registered

2018-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: null- Prevention of postoperative nausea and vomiting (PONV) following laparoscopic gynaecological surgeries

Interventions

Control Intervention1: Palonosetron compared to ondansetron: Palonosetron is a second generation serotonin 5-HT3 receptor antagonist. Unlike other antagonists, it is a potent 5-HT3 receptor antagonist

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical grade â?? I and II, Non â??smoker Weight â?? 40-90 kg Surgery â?? Elective laparoscopic gynaecological surgeries.

Exclusion criteria

Exclusion criteria: Body weight > 90 kg Known hypersensitivity to serotonin antagonists History of motion sickness, PONV Pregnant patients, Lactating mothers. Patients with ongoing gastrointestinal disease Disorder of any major organ function like liver, lung, heart or bone marrow. Patients who received chemotherapy in last few weeks, who are on antiemetics, psychomimetics or steroids preoperatively. Patients who are unable to cooperate with the investigators Patients who are not willing to participate in the study.

Design outcomes

Primary

Measure	Time frame
Total number of PONV episodes in the 48hrs period following conclusion of anaesthesia. Timepoint: PONV scores between 0-2, 2-24 and 24-48 hrs period following conclusion of anaesthesia.	—

Secondary

Measure	Time frame
Frequency of nausea, retching and vomiting episodes, individually, in the 48hrs period following conclusion of anaesthesiaTimepoint: 0-2, 2-24 and 24-48 hrs;Overall satisfaction with the PONV, nausea-vomiting experience (dissatisfied, neutral, satisfied) at 48hrs after surgery completion.Timepoint: upto 48 hrs after procedure;The amount of dexamethasone (used as second line or ultimate rescue antiemetic drug) required. Timepoint: upto 48 hrs after procedure;The number of complete responders â?? no PONV episodes and no need for rescue medication.Timepoint: upto 48 hrs after procedure;The total amount of Ondansetron (used as first line rescue antiemetic drug) required in each groupTimepoint: upto 48 hrs after procedure	—

Measure

Time frame

Frequency of nausea, retching and vomiting episodes, individually, in the 48hrs period following conclusion of anaesthesiaTimepoint: 0-2, 2-24 and 24-48 hrs;Overall satisfaction with the PONV, nausea-vomiting experience (dissatisfied, neutral, satisfied) at 48hrs after surgery completion.Timepoint: upto 48 hrs after procedure;The amount of dexamethasone (used as second line or ultimate rescue antiemetic drug) required. Timepoint: upto 48 hrs after procedure;The number of complete responders â?? no PONV episodes and no need for rescue medication.Timepoint: upto 48 hrs after procedure;The total amount of Ondansetron (used as first line rescue antiemetic drug) required in each groupTimepoint: upto 48 hrs after procedure

—

Countries

India

Contacts

Public ContactRohit

Dept.of Anaesthesiology Indraprastha Apollo Hospital New Delhi

jaisunny1@hotmail.com9891048869

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026