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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734929
• Other study ID #: Pro00001404
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2008
• Last updated: February 12, 2016
• Start date: September 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

A patient is eligible for inclusion in this study if all of the following criteria apply:

• 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.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant + Dexamethasone
Aprepitant 40 mg + Dexamethasone 10 mg
• Ondansetron + Dexamethasone
Ondansetron 4 mg + Dexamethasone 10 mg

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & 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 craniot — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Incidence of Emesis	Any vomiting or retching	48 h	No
Secondary	Incidence of Nausea	operative procedure	Post operative procedure (OP) hours (0-2, 24, 48)	No
Secondary	Incidence of Vomiting		Post OP (0 - 2 hours)	No
Secondary	Incidence of Vomiting	Any vomiting or retching	24 h	No
Secondary	Use of Rescue Antiemetics		Post OP (0 - 2 hours)	No
Secondary	Use of Rescue Antiemetics		24 h	No
Secondary	Use of Rescue Antiemetics		48 hour	No
Secondary	Number of Participants With a Complete Response Rate	complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.	24 hours Post OP, 48 hours Post OP	No
Secondary	Average Nausea Score	Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable	Post OP hours 0-2, 24 h, 48 h	No
Secondary	Number of Vomiting Episodes		48 hours	No
Secondary	Time to First Vomiting		48 h	No
Secondary	Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"	Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)	48 hour	No