Phase 2 N=50 Treatment

Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT02457195 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea — 8; 25; 24; 28 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: granisetron (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea	8; 25; 24; 28; 18; 25	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT02457195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.