Cytokines and Sevoflurane During Surgery | NCT01231477

Studies
Cytokines and Sevoflurane During Surgery

NCT01231477

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Completed

Last Update Posted

Nov 1, 2010Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Cytokines
Inflammatory
Sevoflurane

Interventions

Not provided

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

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

Oct 2010

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

Jul 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Oct 29, 2010

First Submission Date that Met QC Criteria

Oct 29, 2010

First Posted Date

Nov 1, 2010Estimated

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

Oct 29, 2010

Last Update Posted Date

Nov 1, 2010Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

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 aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Volunteers		Healthy volunteers not submitted to anesthesia nor surgery.
Sevoflurane Group		This group was submitted to inhalational anesthesia with sevoflurane and otorhinolaryngological surgery.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty.

Exclusion Criteria:

Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Thirty adult patients ASA I physical status were allocated in 2 grups: 15 volunteers, not submitted to anesthesia and surgery, and 15 patients scheduled for tympanoplasty or septoplasty anesthetized with sevoflurane at 2,5%. Blood samples were drawn at 4 moments: before induction of anaesthesia, before surgery, at 120 minutes after anaesthesia induction, and on the postoperative first day. Blood samples from volunteers were drawn only once.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose EB Orosz, MD	Botucatu Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Botucatu Medical School		Botucatu	São Paulo	18618-970	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided