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A study comparing three medicines used for preventing post operative nausea and vomiting in patients undergoing craniotomy surgeries

Comparision of efficacy of ondansetron versus palanosetron versus ramosetron for prevention of post operative nausea and vomiting (PONV) in elective craniotomy surgeries- A randomized double blinded prospective study - PONV

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101436
Enrollment
162
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: C7A8- Other malignant neuroendocrine tumors Health Condition 2: C7A8- Other malignant neuroendocrine tumors

Interventions

Intervention1: PALONOSETRON: 2nd generation 5HT3 receptor antagonist, Dose - 1mcg/kg, intravenous, at the time of closure of dura, duration of action - more than 24 hours Intervention2: RAMOSETRON: 2n

Sponsors

DR ASHWITHA VAIDYA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA PHYSICAL STATUS 1, 2 UNDERGOING ELECTIVE CRANIOTOMY SURGERIES

Exclusion criteria

Exclusion criteria: Patients aged less than 19 and more than 65, belonging to ASA class 3 or more, patients having gastric diseases,history of vomiting, history of craniotomy,on antibiotics cancer chemotherapy, anti emetic use within 24hours, severe renal or hepatic insufficiency,borderline QT prolongation, chronic use of opioids ,on antidepressant medication, undergoing emergency surgeries with poor GCS , who could not communicate,pregnant

Design outcomes

Primary

MeasureTime frame
To evaluate and compare for the incidence of complete response ( no nausea, no vomiting, no use of rescue medication)Timepoint: In first 48 hours between three groups

Secondary

MeasureTime frame
To evaluate & compare for the incidence of vomiting, retching, nausea ( intensity/ severity)Timepoint: 0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS POSTOPERATIVELY;To compare side effects profile between three groupsTimepoint: 0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS POSTOPERATIVELY;To look for the need for rescue anti emeticTimepoint: 0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS;To evaluate patient satisfaction using Likert scale between three groupsTimepoint: 48 HOURS POSTOPERATIVELY

Countries

India

Contacts

Public ContactDR ASHWITHA VAIDYA

NIZAMS INSTITUTE OF MEDICAL SCIENCES

ASHWITHAVAIDYA97@GMAIL.COM9542419135

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026