Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT00717054
First received: July 15, 2008
Last updated: May 1, 2014
Last verified: September 2013
  Purpose

The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without transdermal scopolamine preoperatively.


Condition Intervention
Nausea
Vomiting
Drug: Aprepitant
Drug: Scopolamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Number of Participants With Nausea and Vomiting [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Nausea and Vomiting in PACU [ Time Frame: Postoperatively, up to 2 hours ] [ Designated as safety issue: No ]
  • Total Vomiting [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Need for Antiemetic Medication [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aprepitant and Scopolamine group
Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Drug: Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Other Name: Emend
Drug: Scopolamine
Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Other Names:
  • Scopace
  • Transdermal scopolamine
Placebo Comparator: Aprepitant and Scopolamine Placebo Group
Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.
Drug: Scopolamine
Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
Other Names:
  • Scopace
  • Transdermal scopolamine

Detailed Description:

Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucleus tractus solitaries in the brain. Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response.

Scopolamine antagonizes muscarinic type 1 (M1) and histamine type 1 (H1) receptors in the CNS, hypothalamus, and vomiting center. The noradrenergic system is also suppressed resulting in a diminished response to vestibular stimulation. Surgical procedures, opioids, and movement postoperatively all stimulate the vestibular system making scopolamine effective prophylaxis for PONV.

In adults undergoing general anesthesia with inhalational anesthetic agents, predictive risk factors for PONV include female sex, history of PONV or motion sickness, nonsmoking status, and the use of postoperative opioids. The frequency of PONV is 10% with zero, 21% with one, 39% with two, 61% with three, and 79% with 4 risk factors. The type of surgery also plays a major role. High risk procedures include intrabdominal, laparoscopic, orthopedic, major gynecologic, thyroid, otolaryngological, neurosurgical, breast, and plastic surgery.

Improving PONV prophylaxis would have a profound impact on patient care. Decreasing the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned admissions is beneficial. Recent evidence suggests multiple drug therapy is superior to single agents. The correct preoperative treatment medication is instrumental in the outcome. This study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 65 years of age
  • American Society of Anesthesiology (ASA) physical status 1-3
  • If on oral contraceptive, must be willing to use back up method for 1 month
  • Must have 2 risk factors for PONV

Exclusion Criteria:

  • History of vomiting due to middle ear infection, nervous system disorder, or other condition
  • Procedure less than 1 hour
  • Pregnant or breast feeding
  • Antiemetic medication in previous 24 hours
  • Narrow-angle glaucoma
  • Allergic to belladonna alkaloids
  • Hypersensitive to barbiturates
  • Prostate hypertrophy
  • Severe hepatic disease
  • On chemotherapy taking aprepitant
  • Fever
  • Sepsis
  • Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717054

Locations
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Michael S Green, DO Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT00717054     History of Changes
Other Study ID Numbers: 00659737
Study First Received: July 15, 2008
Results First Received: March 5, 2014
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
postoperative nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Aprepitant
Fosaprepitant
Butylscopolammonium Bromide
Scopolamine Hydrobromide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adjuvants, Anesthesia
Mydriatics

ClinicalTrials.gov processed this record on September 18, 2014