Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

NCT01474915 | Completed Phase 4 Results DMC

• 1 other identifier: 2007H0053
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine the efficacies of two preventative drug combinations for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this study is to compare the efficacy of using aprepitant instead of ondansetron in combination with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By completing this comparison study investigators will determine the most efficacious drug combination which will allow us to enhance the overall comfort and satisfaction of neurosurgical patients in the immediate postoperative period.

Conditions

Postoperative Nausea and Vomiting (PONV); Nausea

Keywords

Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia

  To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia. \- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia. Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia. Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia.

  24 hours post operatively

Secondary Outcomes (1)

• Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale

  24 hours post-operatively

Study Arms (2)

Aprepitant

ACTIVE COMPARATOR

Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia. Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV

Drug: Aprepitant; Drug: Promethazine; Drug: Dexamethasone

Ondansetron

ACTIVE COMPARATOR

Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia. Triple therapy 4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV

Drug: Ondansetron; Drug: Promethazine; Drug: Dexamethasone

Interventions

Aprepitant DRUG

Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction

Also known as: Emend

Aprepitant

Ondansetron DRUG

Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction

Also known as: Zofran

Ondansetron

Promethazine DRUG

Subject will receive 25 mg of Promethazine IV around anesthesia induction

Also known as: •Pentazine, •Phenadoz, •Phenergan, •Phenergan Fortis, •Promacot, •Promethegan

Aprepitant; Ondansetron

Dexamethasone DRUG

Subject will receive 10 mg of Dexamethasone IV around anesthesia induction

Also known as: Decadron, Dexpak

Aprepitant; Ondansetron

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• to 85 years of age
• Scheduled for neurosurgery requiring opening of the cranium and dura at Ohio State University Medical Center and who consent in writing to participate in this study are eligible.

You may not qualify if:

• Patients will be excluded from this study if they are
• prisoners
• pregnant women
• mentally ill
• under the age of 18 or over the age of 85
• American Society of Anesthesiologist (ASA) classification V
• alcohol or drug abusers
• have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50 mmHg.

Sponsors & Collaborators

• Sergio Bergese: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea

Interventions

Aprepitant; Ondansetron; Promethazine; Diphenhydramine; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Propylamines; Amines; Organic Chemicals; Phenothiazines; Sulfur Compounds; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids

Results Point of Contact

• Title: Andrew Otey
• Organization: The Ohio State University Department of Anesthesiology

Andrew.otey@osumc.edu

6142933559

Study Officials

• Sergio D Bergese, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 18, 2011
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 3, 2013
• Results First Posted: December 3, 2013

Record last verified: 2013-11

Locations

US (1)