Back to results

Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Aprepitant

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting

Eligibility Criteria

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

Inclusion Criteria:

female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use

Exclusion Criteria:

liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

Sites / Locations

Gil Medical Center Gachon University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

aprepitant 125mg

Aprepitant 80 mg

Arm Description

NK1 receptor antagonist

Outcomes

Primary Outcome Measures

The numbers (and percentages) of patients who experienced complete response

The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment required rescue therapy and peak nausea scores Adverse effects in the three treatment groups

Secondary Outcome Measures

Full Information

NCT ID

NCT01440673

First Posted

September 20, 2011

Last Updated

September 23, 2011

Sponsor

Gachon University Gil Medical Center

Collaborators

Asan Medical Center, University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT01440673

Brief Title

Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

Collaborators

Asan Medical Center, University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting. NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited. We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.

Detailed Description

123 female patients (ages 21-60) undergoing laparoscopic hysterectomy 80mg aprepitant 125mg aprepitant placebo Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aprepitant 125mg

Arm Type

Active Comparator

Arm Description

NK1 receptor antagonist

Arm Title

Aprepitant 80 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Intervention Description

Aprepitant 80 mg, Aprepitant 125 mg

Primary Outcome Measure Information:

Title

The numbers (and percentages) of patients who experienced complete response

Description

Time Frame

48 hours postoperatively

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use Exclusion Criteria: liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

WOL SEON JUNG, M.D. Ph.D.

Organizational Affiliation

Gil Medical Center Gachon University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gil Medical Center Gachon University

City

Inchon

ZIP/Postal Code

405-760

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

We'll reach out to this number within 24 hrs