Aprepitant for Postoperative Nausea and Vomiting in Lapar... | NCT01440673

Studies
Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

NCT01440673

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Sep 26, 2011Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Sep 20, 2011

First Submission Date that Met QC Criteria

Sep 23, 2011

First Posted Date

Sep 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2011

Last Update Posted Date

Sep 26, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wol Seon Jung, Associate professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Name	Class
Asan Medical Center	OTHER
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aprepitant 125mg	Active Comparator	NK1 receptor antagonist	Drug: Aprepitant
Aprepitant 80 mg	Active Comparator		Drug: Aprepitant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aprepitant	Drug	Aprepitant 80 mg, Aprepitant 125 mg	Aprepitant 80 mg aprepitant 125mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	48 hours postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
WOL SEON JUNG, M.D. Ph.D.	Gil Medical Center Gachon University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gil Medical Center Gachon University		Inchon		405-760	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077608	Aprepitant

Ancestor Terms

ID	Term
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided