Neurokinin Receptor Antagonist Associated to Ondansetron... | NCT02357693

Studies
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

NCT02357693

Sponsor

Instituto do Cancer do Estado de São Paulo

Status

Completed

Last Update Posted

Aug 25, 2015Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Countries

Brazil

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

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

Feb 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jan 31, 2015

First Submission Date that Met QC Criteria

Feb 3, 2015

First Posted Date

Feb 6, 2015Estimated

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

Aug 24, 2015

Last Update Posted Date

Aug 25, 2015Estimated

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

The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

Detailed Description

High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aprepitant	Experimental	aprepitant 80 mg one hour before surgery	Drug: Aprepitant
placebo	Placebo Comparator	oral placebo one hour before surgery	Drug: Aprepitant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aprepitant	Drug	Aprepitant or placebo will be administered to the patient before surgery	aprepitant placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of nausea and vomiting in postoperative period		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

high risk patients for nausea and vomiting

Exclusion Criteria:

cardiovascular disease, or hypersensibility to any of the drugs involved in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hazem a Ashmawi, phD	University of Sao Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angela Maria Sousa		São Paulo	São Paulo	01403010	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25220550	Result	Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.

Type	Date	Date Unknown
Release	Jan 29, 2018
Reset	Sep 27, 2018
Release	May 14, 2021
Reset	Jun 8, 2021
Release	Dec 17, 2021
Reset	Mar 4, 2022

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 29, 2018			Sep 27, 2018
May 14, 2021

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

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