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

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Post-operative Nausea and Vomiting

Treatments: Drug: Ondansetron 4 MG; Drug: Ondansetron 8mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03297021

GCO 17-1618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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141 participants in 3 patient groups, including a placebo group

Ondansetron 4mg Pre-emergence

Placebo Comparator group

Treatment:

Drug: Ondansetron 4 MG

Ondansetron 8mg Pre-emergence

Experimental group

Treatment:

Drug: Ondansetron 8mg

Ondansetron Pre-Incision and Pre-emergence

Experimental group

Description:

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

Treatment:

Drug: Ondansetron 4 MG