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Comparing two drugs (Aprepitant versus Ondansetron) to decrease the number of episodes of nausea and vomiting in patients undergoing surgery for removal of tumour from certain areas of brain.

Comparing the efficacy of Aprepitant Vs Ondansetron for the prevention of post-operative nausea vomiting (PONV) in patients undergoing posterior fossa craniotomy for excision of tumour causing brainstem compression â?? A double blind randomised controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035172
Enrollment
170
Registered
2021-07-27
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: C717- Malignant neoplasm of brain stem Health Condition 2: C716- Malignant neoplasm of cerebellum Health Condition 3: C714- Malignant neoplasm of occipital lobe

Interventions

Intervention1: Aprepitant: NK1 Antagonist. Will be administered as 80mg capsule per oral one hour prior to surgery, single dose Control Intervention1: Ondansetron: HT3 antagonist, Will be administered

Sponsors

Christian Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients aged between 18-70 years, ASA grade I-III undergoing posterior fossa craniotomy for excision of tumour.

Exclusion criteria

Exclusion criteria: 1. Extremes of age 70 years 2. ASA IV 3. Patients with known allergies to the drugs being used 4. Patients with QT prolongation (Corrected QTc > 440 sec) 5. Patients with planned/ unplanned postoperative ventilation 6. Patients who are on NG tube or who need NG tube placement post-surgery

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative retching and/or vomiting 24-hours post- surgeryTimepoint: 0-24hrs—

Secondary

MeasureTime frame
Incidence of postoperative retching and/or vomiting from 24 hours to 48 hours after surgery.Timepoint: 24 to 48hrs;Incidence of severity of nausea during the first 48 hours.Timepoint: 0-48hrs;Incidence of tumour bed hematoma needing re-exploration.Timepoint: 0-48hrs;Requirement of rescue antiemetics during the first 24 hourpostoperative period.Timepoint: 0-24hrs—

Countries

India

Contacts

Public ContactDr Joanna Preritha Fernandes

Christian Medical College, Vellore

ramamani@cmcvellore.ac.in9573310190

Outcome results

None listed

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