Dexamethasone Reduces Postoperative Emesis by Decreasing... | NCT01811199

Studies
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

NCT01811199

Sponsor

Marmara University

Status

Unknown status

Last Update Posted

Mar 14, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Thyroid Cancer
Breast Cancer

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Apr 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 12, 2013

First Posted Date

Mar 14, 2013Estimated

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

Mar 12, 2013

Last Update Posted Date

Mar 14, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.

Detailed Description

This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis	participants will be followed for the duration of hospital stay, till they are discharged in avarage 3 days for postoperative emesis.	up to 3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent

Exclusion Criteria:

ones who did not sign the consent form NSAID or steroid users

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing thyroidectomy and mastectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A.Ozdemir Aktan, MD,prof	Marmara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University School of Medicine		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms
D001943	Breast Neoplasms
D014839	Vomiting

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided