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

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

Sponsors

Lead Sponsor: Yonsei University

Source Yonsei University
Brief 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.

Overall Status Completed
Start Date June 2012
Completion Date June 2013
Primary Completion Date June 2013
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
incidence and severity of postoperative nausea and vomiting upto 2 days after surgery
Secondary Outcome
Measure Time Frame
adverse event upto 2 days after surgery
pain upto 2 days after surgery
Enrollment 125
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aprepitant

Description: 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.

Arm Group Label: Aprepitant group

Other Name: Emend

Intervention Type: Drug

Intervention Name: placebo

Description: 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.

Arm Group Label: placebo group

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 20 Years

Maximum Age: 60 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Yon Hee Shim Study Director Yonsei University
Location
Facility: Gangnam severance hospital
Location Countries

Korea, Republic of

Verification Date

July 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Yonsei University

Investigator Full Name: Yon Hee Shim

Investigator Title: MD, PhD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Aprepitant group

Type: Experimental

Description: We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room)

Label: placebo group

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov