The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897337
• Other study ID #: 3-2012-0076
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2013
• Last updated: July 8, 2013
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.

So, we should prevent PONV in these patients by using multimodal or combination therapy.

Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.

In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient undergoing laparoscopic gynecologic surgery.

• Patient who takes fentanyl based IV PCA

• ASA class I-II

Exclusion Criteria:

• allergy to aprepitant

• take another antiemetics before surgery

• decreased liver function

• psychological disease

• who cannot speak Korean

• take medicines that interacts with emend who do not agree to the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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
We administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
• placebo
Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of postoperative nausea and vomiting	Severity of PONV will be measured by using verbal numerical rating scale (0-10).; Incidence of retching or vomiting will also be recorded upto 2 days after surgery.	upto 2 days after surgery	No
Secondary	adverse event	abdominal pain, headache, diziness, drowsiness, constipation, pruritus, etc	upto 2 days after surgery	No
Secondary	pain	Pain is assessed with verbal numeric rating scale. (0-10)	upto 2 days after surgery	No