Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane

Patients in Good Health Clinical Trial

Official title:

Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111227
• Other study ID #: upeclin/HC/FMB-Unesp-40
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2010
• Last updated: April 26, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Twenty ASA-I patients, subjected to otorhinolaryngology surgery, were randomly allocated in one group to receive anesthesia with isoflurane 1 MAC (minimum alveolar concentration) (n = 20). Other group with twenty ASA-I patients received propofol 2 to 4 microgram mL-1 (n = 20).

Fentanyl 5 mg kg-1 and rocuronium bromide 0.6 mg kg-1 were also administered to all patients. Venous blood (10 mL) was collected from each patient at each of the following times: before the beginning of surgery and anesthesia (T1), 2 h after the beginning of surgery (T2), and on the day after the anesthetic-surgical procedure (T3).

Plasma concentrations of interleukins IL-1beta, IL-6, IL-8, IL-10 and IL-12 and tumor necrosis factor (TNF-alpha) were measured in each sample through flow cytometry technique by using the method Cytometric Bead Array (CBA). Venous blood samples from fifteen volunteers not subjected to stress were also collected as control, and the same cytokines were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients in good health American Society of Anesthesia status physical I

• Elective minor surgery

• General anesthesia

Exclusion Criteria:

• Smokers

• Alcoholics

• Previous medication or radiation

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Patients in Good Health

Intervention

Drug:
• Propofol and isoflurane
Comparison of two anesthetic drugs

Locations

Country	Name	City	State
Brazil	Botucatu Medical School, UNESP	Botucatu	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of cytokines profile		Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery	Yes
Secondary	Evaluation of pro and anti-inflammatory cytokines		before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery	Yes