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

NCT03297021 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 17-1618
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Nausea and Vomiting

Keywords

ambulatory surgery; post-operative nausea and vomiting; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Episodes of Vomiting in the PACU

  average of 4 hours

• Number of Participants With Symptoms on POD 1

  Day 1

• Number of Participants Who Needed Rescue Anti-emetics

  average of 4 hours

• Total Anesthesia Time

  intraoperative, up to 3.5 hours

Study Arms (3)

Ondansetron 4mg Pre-emergence

PLACEBO COMPARATOR

Drug: Ondansetron 4 MG

Ondansetron 8mg Pre-emergence

EXPERIMENTAL

Drug: Ondansetron 8mg

Ondansetron Pre-Incision and Pre-emergence

EXPERIMENTAL

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

Drug: Ondansetron 4 MG

Interventions

Ondansetron 4 MG DRUG

dose as per arm selection

Ondansetron 4mg Pre-emergence; Ondansetron Pre-Incision and Pre-emergence

Ondansetron 8mg DRUG

dose as per arm selection

Ondansetron 8mg Pre-emergence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

You may not qualify if:

• Patients with allergies or contraindications to study medications

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dr. Daniel Katz
• Organization: Icahn School of Medicine at Mount Sinai

Daniel.Katz@mountsinai.org

212-241-7475

Study Officials

• Daniel Katz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: October 23, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)