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

Overview

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.

Full Title of Study: “Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: April 5, 2019

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.

Interventions

  • Drug: Ondansetron 4 MG
    • dose as per arm selection
  • Drug: Ondansetron 8mg
    • dose as per arm selection

Arms, Groups and Cohorts

  • Placebo Comparator: Ondansetron 4mg Pre-emergence
  • Experimental: Ondansetron 8mg Pre-emergence
  • Experimental: Ondansetron Pre-Incision and Pre-emergence
    • 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • Total Anesthesia Time
    • Time Frame: intraoperative, up to 3.5 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daniel Katz, Assistant Professor – Icahn School of Medicine at Mount Sinai
  • Overall Official(s)
    • Daniel Katz, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai

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