Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

• Status: Completed
• Trial end date: 2018-02-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Granisetron

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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