NCT01231477

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
Last Updated

November 1, 2010

Status Verified

October 1, 2010

Enrollment Period

5 months

First QC Date

October 29, 2010

Last Update Submit

October 29, 2010

Conditions

Keywords

anaesthetic techniques, inhalationsevofluraneCytokinesImmune response

Study Arms (2)

Volunteers

Healthy volunteers not submitted to anesthesia nor surgery.

Sevoflurane Group

This group was submitted to inhalational anesthesia with sevoflurane and otorhinolaryngological surgery.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botucatu Medical School

Botucatu, São Paulo, 18618-970, Brazil

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose EB Orosz, MD

    Botucatu Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 1, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

November 1, 2010

Record last verified: 2010-10

Locations