NCT03297021

Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting

Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Detailed description

Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.

Conditions

• Post-operative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Ondansetron 4 MG	dose as per arm selection
DRUG	Ondansetron 8mg	dose as per arm selection

Timeline

• Start date: 2017-10-23
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2017-09-29
• Last updated: 2020-07-20
• Results posted: 2020-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study