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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02056561
Other study ID # MESUT-81
Secondary ID
Status Completed
Phase N/A
First received January 29, 2014
Last updated February 5, 2014
Start date January 2010
Est. completion date January 2011

Study information

Verified date February 2014
Source Duzce University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of anesthesia and studies have shown that these anesthetics cause a variety of changes in oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol infusion anesthesia on the oxidant and antioxidant systems of patients undergoing laparoscopic cholecystectomy.

Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II, score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia were included in the study. Patients were divided into 3 groups as total intravenous anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2011
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- ASA I-II with patients

- Between 18-50 years

- Planned laparoscopic cholecystectomy under general anesthetic

Exclusion Criteria:

- Patients with endocrine dysfunction

- blood transfusion in the previous 2 weeks

- signs of infection and inflammation

- history of preoperative medication use

- anemia

- hemorrhage requiring transfusion during the operation were excluded from the study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Duzce Univercity Medical Fauculty Duzce

Sponsors (1)

Lead Sponsor Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of glutathion peroxidase, total oxidants and antioxidants. Before induction and after the operation venous blood samples were taken to evaluate the levels of glutathion peroxidase, total oxidants and antioxidants. 24 hours Yes
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