- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02209883
The Effect of Sevofluorane on Wash-out Time in COPD (washout)
The Effects of Chronic Obstructive Pulmonary Disease on the Washout Time of Sevofluorane Anesthesia
Study Overview
Status
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:
- Cardiac failure
- Hepatic failure
- Renal failure
- Neurologic diseases
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Duzce, Turkey, 81620
- Duzce Univercity Medical Fauculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group normal
The patients which have not clinical diagnosis of chronic obstructive lung disease.
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Group COPD
The patients which have chronic obstructive lung disease in clinical evaluation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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washout time
Time Frame: second
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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
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second
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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extubation time
Time Frame: seconds
|
The time which sevoflurane MAC level decrease 1 MAC to extubation
|
seconds
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ilknur Suidiye Seker, Asist. prof., Duzce University School of Medicine
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- sevofluorane washout time COPD
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