Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

NCT00734929 | Completed Phase 4 Results

• 1 other identifier: Pro00001404
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; nausea; emesis; antiemetics; aprepitant; ondansetron; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Emesis

  Any vomiting or retching

  48 h

Secondary Outcomes (11)

• Incidence of Nausea

  Post operative procedure (OP) hours (0-2, 24, 48)

• Incidence of Vomiting (Post OP)

  Post OP (0 - 2 hours)

• Incidence of Vomiting (24 Hours)

  24 h

• Use of Rescue Antiemetics (Post OP)

  Post OP (0 - 2 hours)

• Use of Rescue Antiemetics (24 Hours)

  24 h

Study Arms (2)

1

EXPERIMENTAL

Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia

Drug: Aprepitant + Dexamethasone

2

ACTIVE COMPARATOR

Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia

Drug: Ondansetron + Dexamethasone

Interventions

Aprepitant + Dexamethasone DRUG

Aprepitant 40 mg + Dexamethasone 10 mg

1

Ondansetron + Dexamethasone DRUG

Ondansetron 4 mg + Dexamethasone 10 mg

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years of age
• Surgery: craniotomy under general anesthesia.
• American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
• Language: Fluent in the English language
• Informed Consent: Written informed consent must be obtained.

You may not qualify if:

• Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
• Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
• Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
• Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
• Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
• Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
• Nausea verbal rating score (VRS): A VRS nausea score \> 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.

Sponsors & Collaborators

• Duke University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Habib AS, Keifer JC, Borel CO, White WD, Gan TJ. A comparison of the combination of aprepitant and dexamethasone versus the combination of ondansetron and dexamethasone for the prevention of postoperative nausea and vomiting in patients undergoing craniotomy. Anesth Analg. 2011 Apr;112(4):813-8. doi: 10.1213/ANE.0b013e3181ff47e2. Epub 2010 Nov 16.

  PMID: 21081776 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Aprepitant; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dr. Ashraf Habib
• Organization: Duke University Medical Center

habib001@mc.duke.edu

9196686265

Study Officials

• Ashraf S Habib, MBBCH, FRCA

  Duke 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

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 13, 2017
• Results First Posted: June 3, 2011

Record last verified: 2017-01

Locations

US (1)