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

NCT ID: NCT01897337

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Aprepitant group

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

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

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 group

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Emend

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yon Hee Shim

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yon Hee Shim

Role: STUDY_DIRECTOR

Yonsei University

Locations

Gangnam severance hospital

Seoul, , South Korea

Countries

South Korea

References

Ham SY, Shim YH, Kim EH, Son MJ, Park WS, Lee JS. Aprepitant for antiemesis after laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):90-5. doi: 10.1097/EJA.0000000000000242.

Reference Type: DERIVED

PMID: 26694939 (View on PubMed)

Other Identifiers

3-2012-0076

Identifier Type: -

Identifier Source: org_study_id