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

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

Sponsors

Lead sponsor: Icahn School of Medicine at Mount Sinai

Source Icahn School of Medicine at Mount Sinai
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.

Overall Status Completed
Start Date October 23, 2017
Completion Date April 5, 2019
Primary Completion Date April 5, 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Post-operative nausea and vomiting average of 4 hours
Secondary Outcome
Measure Time Frame
Episodes of vomiting in the PACU average of 4 hours
Presence of nausea or vomiting on post-operative day one Day 1
Number of additional treatments needed to control nausea or vomiting in the PACU average of 4 hours
Time to discharge from PACU average of 4 hours
Enrollment 140
Condition
Intervention

Intervention type: Drug

Intervention name: Ondansetron 4 MG

Description: dose as per arm selection

Intervention type: Drug

Intervention name: Ondansetron 8mg

Description: dose as per arm selection

Arm group label: Ondansetron 8mg Pre-emergence

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Daniel Katz, MD Principal Investigator Icahn School of Medicine at Mount Sinai
Location
facility
Icahn School of Medicine at Mount Sinai
Location Countries

United States

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Icahn School of Medicine at Mount Sinai

Investigator full name: Daniel Katz

Investigator title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Ondansetron 4mg Pre-emergence

Arm group type: Placebo Comparator

Arm group label: Ondansetron 8mg Pre-emergence

Arm group type: Experimental

Arm group label: Ondansetron Pre-Incision and Pre-emergence

Arm group type: Experimental

Description: 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Prevention

Masking: Triple (Participant, Care Provider, Outcomes 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.

Source: ClinicalTrials.gov