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

NCT ID: NCT03297021

Last Updated: 2020-07-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2019-04-05

Brief Summary

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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.

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Detailed Description

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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

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Post-operative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.

Study Groups

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Ondansetron 4mg Pre-emergence

Group Type PLACEBO_COMPARATOR

Ondansetron 4 MG

Intervention Type DRUG

dose as per arm selection

Ondansetron 8mg Pre-emergence

Group Type EXPERIMENTAL

Ondansetron 8mg

Intervention Type DRUG

dose as per arm selection

Ondansetron Pre-Incision and Pre-emergence

4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence

Group Type EXPERIMENTAL

Ondansetron 4 MG

Intervention Type DRUG

dose as per arm selection

Interventions

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Ondansetron 4 MG

dose as per arm selection

Intervention Type DRUG

Ondansetron 8mg

dose as per arm selection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with allergies or contraindications to study medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Daniel Katz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GCO 17-1618

Identifier Type: -

Identifier Source: org_study_id

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