Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

NCT02457195 | Completed Phase 2 Results DMC

• 1 other identifier: HRP-592
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; anesthesia; granisetron

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea

  Composite measure consisting of complete response (CR), defined as no emetic episode and no rescue medication; the proportions of patients with no emesis and no additional rescue medication in the 120 hours following the completion of surgical procedure.

  24 hrs, 48 hrs, 72 hrs and 120 hrs

Study Arms (1)

Admnistration of granisetron

EXPERIMENTAL

Preoperative administration of granisetron transdemal patch

Drug: granisetron

Interventions

granisetron DRUG

Application granisetron transdermal patch preoperatively

Also known as: Sancuso

Admnistration of granisetron

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Piotr Janicki
• Organization: The Pennsylvania State University College of Medicine

pjanicki@pennstatehealth.psu.edu

7175315680

Study Officials

• Piotr K Janicki, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 29, 2015
• Study Start: February 1, 2016
• Primary Completion: February 19, 2018
• Study Completion: February 19, 2018
• Last Updated: December 18, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (1)