Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

NCT ID: NCT02457195

Last Updated: 2019-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-02-19

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.

Detailed Description

Patients will be recruited from the surgical population undergoing preoperative evaluation in Anesthesiology Preoperative Evaluation Clinic at Hershey Med. Ctr. (~15,000 per year). Selected patients (ASA 1-3, N=60) with history of severe PONV after one or more of previous general anesthesia, and scheduled to undergo surgical procedures with general anesthesia will be enrolled into IRB approved protocol. The patch will be placed by the patient at home 24 - 48 hours before surgery as directed by the doctor. The subsequent standardized general anesthesia protocol for elective surgery will include general endotracheal anesthesia with sevofluran, including standard intraoperative PONV prophylaxis (IV dexamethasone and IV ondansetron, each 4 mg). Postoperative evaluation will include recording of incidence and severity of PONV at the time of discharge from PACU (acute PONV), at 24 hr, 48 hrs, 72 and 120 hrs (delayed or post discharge PONV).

7.2.1 Visit 1 - Anesthesia Preoperative Evaluation Clinic and recruitment and drug dispensation Patient is seen in clinic and identified as having a history of serious PONV, in particular delayed or post discharge PONV. Study will be explained to the patient and consent obtained. The investigational pharmacy will be notified that a study patient has been enrolled and they will prepare the patches for distribution to the patient.

A member of the research team will obtain the assigned patches from the investigational pharmacy and deliver to the anesthesia provider (member of the research team).

The provider will then demonstrate to the patient how to apply the patch and the patient can practice using a placebo patch to show that the correct placement. Patient will then take the actual patch home with them.

7.2.2 Visit 2 - approximately 24-48 hours preoperatively (patient's home) Patient will apply the patch to their upper arm 24-48 hours before scheduled surgical procedure, as instructed during their pre-op anesthesia visit. The patch will then remain in place until 120 hours after surgical procedure. No backup patch will be provided so the patients with the accidently missing patch will need to call their primary surgical service for the standard antiemetic medication.

7.2.3 Visit 3- Day of Surgery Patient will arrive for surgery. A member of the research team will meet them in the SDU and record the time that the patch was applied, and if it has been placed correctly, intact and still in place. Any potential side effects (systemic or local) will be recorded at that time. The subsequent standardized general anesthesia protocol for elective surgery will include general endotracheal anesthesia with sevofluran (no nitrous oxide), muscle relaxants (with reversal), intraoperative IV opioid analgesics, including standard PONV prophylaxis (dexamethasone and ondansetron IV 4 mg).

Early postoperative evaluation will include recording of incidence and severity of PONV at the time of discharge from PACU (acute PONV). The incidence of vomiting or retching will recorded by the nursing staff. Patients with symptoms requiring a rescue antiemetic-nausea score ≥4 on an 11-point Numeric Rating Scale (NRS), retching or vomiting, or patient request-within 6 hours of PACU admission will be given the rescue medication (Benadryl or promethazine). The NRS was an 11-point linear scale on which patients rated their nausea, with 0 meaning no nausea and 10 meaning the worst possible nausea.

The subsequent evaluations will be performed either at the patient's bed (if in the hospital) or by phone call at 24 hr, 48 hrs, 72 and 120 hrs (delayed or post discharge PONV). The patient will be supplied with a diary to record the information that will be requested on the follow-up phone calls.

The primary efficacy endpoint will be 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. Treatment-emergent adverse events (TEAEs), regardless of suspected causal relationship to the study medication, will be also recorded throughout and continued until 5 days after surgery.

7.3 Duration of Participation Patient will remain in the study until all time points have been met (maximum 5 days following surgery or 120 hours). At the end of the study the patient will remove and dispose the remaining patch.

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; anesthesia; granisetron

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Admnistration of granisetron

Preoperative administration of granisetron transdemal patch

Group Type: EXPERIMENTAL

granisetron

Intervention Type: DRUG

Application granisetron transdermal patch preoperatively

Interventions

granisetron

Application granisetron transdermal patch preoperatively

Intervention Type: DRUG

Other Intervention Names

Sancuso

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Piotr K Janicki MD, PhD

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piotr K Janicki, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HRP-592

Identifier Type: -

Identifier Source: org_study_id