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Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

NCT02457195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-12-18

Study results available
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Summary

The objective of the study is to evaluate the efficacy and safety of adding transdermal preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing surgical procedure under general anesthesia.

The specific aims of the study include:

1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery
2. incidence and seriousness of the observed side effects
3. ability of patients to self-administer preoperatively and maintain the investigated patch during the perioperative period
4. level of satisfaction with the preoperative PONV prophylaxis.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

granisetron

Application granisetron transdermal patch preoperatively

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Piotr K Janicki, MD · Penn State College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-19
Completion
2018-02-19

Countries

  • United States

Study Locations

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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 NCT02457195 on ClinicalTrials.gov