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

Post-operative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297021
• Other study ID #: GCO 17-1618
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: July 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Post-operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Total Anesthesia Time		intraoperative, up to 3.5 hours