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Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting (GTPPONV)

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ClinicalTrials.gov Identifier: NCT02457195
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Piotr K Janicki MD, PhD, Milton S. Hershey Medical Center

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. 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: granisetron Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Use of Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting (PONV) in Patients With History of Severe PONV - Open Label, Prospective, Pilot Study
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 19, 2018
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Granisetron

Arm Intervention/treatment
Experimental: Admnistration of granisetron
Preoperative administration of granisetron transdemal patch
Drug: granisetron
Application granisetron transdermal patch preoperatively
Other Name: Sancuso




Primary Outcome Measures :
  1. Effectiveness of prophylactic activity in prevention of PONV [ Time Frame: 120 hours ]
    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 and the change from baseline nausea score using the NRS.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457195


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Piotr K Janicki, MD Penn State College of Medicine

Responsible Party: Piotr K Janicki MD, PhD, Professor of Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02457195     History of Changes
Other Study ID Numbers: HRP-592
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Keywords provided by Piotr K Janicki MD, PhD, Milton S. Hershey Medical Center:
PONV
anesthesia
granisetron

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action