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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aprepitant
placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aprepitant group

placebo group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

adverse event
abdominal pain, headache, diziness, drowsiness, constipation, pruritus, etc
pain
Pain is assessed with verbal numeric rating scale. (0-10)

Full Information

First Posted
July 8, 2013
Last Updated
July 8, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01897337
Brief Title
The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
Official Title
The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant group
Arm Type
Experimental
Arm Description
We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room)
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention 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.
Primary Outcome Measure Information:
Title
incidence and severity of postoperative nausea and vomiting
Description
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.
Time Frame
upto 2 days after surgery
Secondary Outcome Measure Information:
Title
adverse event
Description
abdominal pain, headache, diziness, drowsiness, constipation, pruritus, etc
Time Frame
upto 2 days after surgery
Title
pain
Description
Pain is assessed with verbal numeric rating scale. (0-10)
Time Frame
upto 2 days after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yon Hee Shim
Organizational Affiliation
Yonsei University
Official's Role
Study Director
Facility Information:
Facility Name
Gangnam severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26694939
Citation
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.
Results Reference
derived

Learn more about this trial

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

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