NCT02056561

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

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

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

January 29, 2014

Last Update Submit

February 5, 2014

Conditions

Keywords

AnesthesiaOxidantsAntioxidants

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

TIVA (group T n: 15)

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.

Sevoflurane (group S n: 15)

Group S were ventilated with 2% sevoflurane, 50% air and 50% O2 mix at 6 L/min flow.

Desflurane (group D n: 15)

Group D cases were given 6% desflurane 50% air and 50% O2 mix at 6 L/min flow.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

45 patients ASA I-II between 18-50 years with planned laparoscopic cholecystectomy under general anesthetic were included in the study. Patients were divided into 3 groups on the way to surgery; TIVA (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n: 15).

You may qualify if:

  • ASA I-II with patients
  • Between 18-50 years
  • Planned laparoscopic cholecystectomy under general anesthetic

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce Univercity Medical Fauculty

Düzce, 81600, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Before induction and after the operation venous blood samples were taken.

Study Officials

  • yavuz demiraran, MD prof

    duzce university medical faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 6, 2014

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

January 1, 2011

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations