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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Nausea and Vomiting
• Intervention / Treatment: Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg

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.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Ondansetron 4mg Pre-emergence	Drug: Ondansetron 4 MG; dose as per arm selection
EXPERIMENTAL: Ondansetron 8mg Pre-emergence	Drug: Ondansetron 8mg; dose as per arm selection
EXPERIMENTAL: Ondansetron Pre-Incision and Pre-emergence; 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence	Drug: Ondansetron 4 MG; dose as per arm selection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2017
• Primary Completion (ACTUAL): April 5, 2019
• Study Completion (ACTUAL): April 5, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): September 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; ambulatory surgery; post-operative nausea and vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: GCO 17-1618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes