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Completed

NCT Number: NCT03297021

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

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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Key information

Conditions

Post-operative Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ondansetron 4 MG

Drug

dose as per arm selection

Ondansetron 8mg

Drug

dose as per arm selection

Primary outcomes

  1. Nausea Scale

    Time frame: average of 4 hours in PACU and POD1

    Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea

Secondary outcomes

  1. Number of Participants With Episodes of Vomiting in the PACU

    Time frame: average of 4 hours

    Number of participants with episodes of vomiting in the Post Anesthesia Care Unit

  2. Number of Participants With Symptoms on POD 1

    Time frame: Day 1

    Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one

  3. Number of Participants Who Needed Rescue Anti-emetics

    Time frame: average of 4 hours

    Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU

  4. Total Anesthesia Time

    Time frame: intraoperative, up to 3.5 hours

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2017
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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