NCT01111227

Brief Summary

The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia with propofol in healthy patients subjected to minimally invasive elective surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

March 11, 2010

Last Update Submit

April 26, 2010

Conditions

Patients in Good Health

Keywords

cytokinespropofolisofluraneflow cytometryTypes of General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Evaluation of cytokines profile

    Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery

Secondary Outcomes (1)

  • Evaluation of pro and anti-inflammatory cytokines

    before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery

Interventions

Propofol and isofluraneDRUG

Comparison of two anesthetic drugs

Also known as: Diprivan, isoflurane

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in good health American Society of Anesthesia status physical I
  • Elective minor surgery
  • General anesthesia

You may not qualify if:

  • Smokers
  • Alcoholics
  • Previous medication or radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botucatu Medical School, UNESP

Botucatu, São Paulo, 18603-970, Brazil

Location

Related Publications (1)

  • Mazoti MA, Braz MG, de Assis Golim M, Braz LG, Dias NH, Salvadori DM, Braz JR, Fecchio D. Comparison of inflammatory cytokine profiles in plasma of patients undergoing otorhinological surgery with propofol or isoflurane anesthesia. Inflamm Res. 2013 Oct;62(10):879-85. doi: 10.1007/s00011-013-0643-y. Epub 2013 Jun 22.

    PMID: 23793449DERIVED

MeSH Terms

Interventions

PropofolIsoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthers

Study Officials

  • Marina Á Mazoti, MsC

    Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2010

First Posted

April 27, 2010

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 27, 2010

Record last verified: 2010-04

Locations

BR(1)