The Effect of Sevofluorane on Wash-out Time in COPD (washout)

August 5, 2015 updated by: Ilknur Suidiye, Duzce University

The Effects of Chronic Obstructive Pulmonary Disease on the Washout Time of Sevofluorane Anesthesia

COPD (Chronic obstructive disease ) is a condition of respiratory system failure seen occasionally in elderly patients of society. Sevofluorane is a safe, volatile anesthetic used considerably widely all over the world. Because respiratory functions and gas exchange became impaired in COPD patients, the respiratory system excretion/washout of inhalational anesthetic agents can be affected. In our study we aimed to investigate if there is a relation between sevofluorane's washout time and the degree of COPD.

Study Overview

Status

Completed

Conditions

Detailed Description

Having approval by the Duzce University non-invasive clinical ethics committee and the written consent, the study was conducted by researchers among 60 American Society of Anesthesiologists (ASA) physical status 1 or 2 patients scheduled for orthopedic, urologic and lower limp surgery which performed under general anesthesia .We investigated patients who have normal pulmonary function and who have chronic obstructive pulmonary disease .We divided into two groups by via questioning and evaluating pulmonary function tests of patients.

The patients were 18-60 years old, with body mass index between 22-29. The exclusion criteria were:

  1. Cardiac failure
  2. Hepatic failure
  3. Renal failure
  4. Neurologic diseases
  5. Endocrine diseases Study design Neither group received premedication. After being taken to the operating room all patients were monitored continuously throughout the study by standard ASA monitors. In addition to standard ASA monitors, inspired oxygen concentration (FiO2 ), inspired and expired concentration of sevofluorane, MAC levels of the patients were monitored.

Anesthesia was induced by propofol (2mg . kg-1), fentanyl (1,5-2 mcg. kg-1), rocuronium(0,6mg. kg-1) intravenously. General anesthesia was maintained by remifentanyl infusion(0,25-1 mcg.kg-1.min-1) and sevofluorane (1 MAC level corrected for the patients age). Fresh gas flow was 6 L. min-1 (50%-50% oxygen/air mixture). Patients were mechanically ventilated (Vt: 6-8 ml. kg-1 , frequency: 9-12 breath.min-1), adjusted to provide an end-tidal CO2 concentration of 35-40 mmHg and SpO2> %95 during anesthetic and surgical procedure.The patients non-invasive arterial tension and heart rate was maintain within normal limits. All data were recorded on each patient's observation charts.

At the end of the surgery, the sevofluorane vaporizer was turned off and the time taken for the sevofluorane concentration to decrease from 1 MAC to 0.3 MAC (MAC awake) and 0.1 MAC were recorded. The ratio of the fraction of inspired of sevoflurane and of expired concentration (Fexp) of sevofluorane at 1 MAC and Fexp of sevofluorane at 0.1 MAC were recorded. Mechanical ventilations of the patients were maintained until extubation and standardized according to ideal body weight. All patients extubated immediately after the patients were given reaction to the endotracheal tube. Remifetanyl infusion was maintained until 0.1 MAC level was reached.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Duzce, Turkey, 81620
        • Duzce Univercity Medical Fauculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the study was conducted by reserchers among 60 American Society of Anesthesiologists (ASA) physical status 1 or 2 patients scheduled for orthopedic, urologic and lower limp surgery which performed under general anesthesia .We investigated patientes who have normal pulmonary function and who have chronic obstructive pulmonary disease .We divided into two groups by via questioning and evaluating pulmonary function tests of patients.

The patients were 18-60 years old, with body mass index between 22-29

Description

Inclusion Criteria:

  • Anesthesiologists (ASA) physical status 1 or 2 patients
  • orthopedic, urologic and lower limp surgery which performed under general anesthesia
  • normal pulmonary function
  • chronic obstructive pulmonary disease

Exclusion Criteria:

  • Cardiac failure
  • Hepatic failure
  • Renal failure
  • Neurologic diseases
  • Endocrine diseases
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group normal
The patients which have not clinical diagnosis of chronic obstructive lung disease.
Group COPD
The patients which have chronic obstructive lung disease in clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
washout time
Time Frame: second
The time in which sevoflurane MAC level decrease from 0.3 MAC to 0.1MAC and 0,1 MAC to extubation in the patients expiratory gases
second

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
extubation time
Time Frame: seconds
The time which sevoflurane MAC level decrease 1 MAC to extubation
seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ilknur Suidiye Seker, Asist. prof., Duzce University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • sevofluorane washout time COPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia

Subscribe