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

Phase 4

Completed

• Conditions: Post-operative Nausea and Vomiting
• Interventions: Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg

• Registration Number: NCT03297021
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Study Start: 2017-10-23
• Primary Completion: 2019-04-05
• Study Completion: 2019-04-05
• Results First Submitted: 2020-06-30
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Results First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

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Exclusion Criteria

• Patients with allergies or contraindications to study medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ondansetron 4mg Pre-emergence	Ondansetron 4 MG	-
Ondansetron Pre-Incision and Pre-emergence	Ondansetron 4 MG	4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Ondansetron 8mg Pre-emergence	Ondansetron 8mg	-

Primary Outcome Measures

Name	Time	Method
Nausea Scale	average of 4 hours in PACU and POD1	Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Needed Rescue Anti-emetics	average of 4 hours	Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
Number of Participants With Episodes of Vomiting in the PACU	average of 4 hours	Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
Number of Participants With Symptoms on POD 1	Day 1	Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
Total Anesthesia Time	intraoperative, up to 3.5 hours

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States