Back to resultsEffects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
Primary Purpose
Post-operative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron 4 MG
Ondansetron 8mg
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Nausea and Vomiting focused on measuring ambulatory surgery, post-operative nausea and vomiting, general anesthesia
Eligibility Criteria
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Ondansetron 4mg Pre-emergence
Ondansetron 8mg Pre-emergence
Ondansetron Pre-Incision and Pre-emergence
Arm Description
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Outcomes
Primary Outcome Measures
Nausea Scale
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
Secondary Outcome Measures
Number of Participants With Episodes of Vomiting in the PACU
Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
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
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
Total Anesthesia Time
Full Information
NCT ID
NCT03297021
First Posted
September 26, 2017
Last Updated
July 17, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03297021
Brief Title
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
Official Title
Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Nausea and Vomiting
Keywords
ambulatory surgery, post-operative nausea and vomiting, general anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron 4mg Pre-emergence
Arm Type
Placebo Comparator
Arm Title
Ondansetron 8mg Pre-emergence
Arm Type
Experimental
Arm Title
Ondansetron Pre-Incision and Pre-emergence
Arm Type
Experimental
Arm Description
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4 MG
Intervention Description
dose as per arm selection
Intervention Type
Drug
Intervention Name(s)
Ondansetron 8mg
Intervention Description
dose as per arm selection
Primary Outcome Measure Information:
Title
Nausea Scale
Description
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
Time Frame
average of 4 hours in PACU and POD1
Secondary Outcome Measure Information:
Title
Number of Participants With Episodes of Vomiting in the PACU
Description
Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
Time Frame
average of 4 hours
Title
Number of Participants With Symptoms on POD 1
Description
Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
Time Frame
Day 1
Title
Number of Participants Who Needed Rescue Anti-emetics
Description
Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
Time Frame
average of 4 hours
Title
Total Anesthesia Time
Time Frame
intraoperative, up to 3.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Katz, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
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