Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

Completed · Phase 2

Conditions studied: Postoperative Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT02457195

Run by

Milton S. Hershey Medical Center

People needed

50

Starts

2016-02-01

Expected to finish

2018-02-19

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients that are between the ages of 18 and 89
• Scheduled to undergo surgical procedures with general anesthesia
• Seen in the anesthesia clinic at least 24 hours before surgery
• History of severe PONV after previous general anesthesia
• Surgical procedures with anticipated duration > 1 hour and no more than 5 hours
• American Society of Anesthesiologists (ASA) physical status I to III

You may not qualify if…

• Allergy to granisetron or other 5HT3RA drugs
• Previous allergic reactions to any drug skin patches
• Recent (less than 1 month) or current chemo- or radiotherapy
• Any nausea, vomiting, or retching within 24 hours prior to anesthesia
• Any type of eye surgeries
• History or diagnosis of gastrointestinal obstruction or ileus
• History of serotonin syndrome
• Unable to sign consent

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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