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Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

NCT02635828 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-05

Study results available
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Summary

Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Palonosetron 0.075 mg IV

At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.

DRUG

Dexamethasone 10 mg IV

At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.

DRUG

Promethazine 25 mg IV

At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Alberto A Uribe, M.D. · Ohio State University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-05-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635828 on ClinicalTrials.gov