The Effect of Sevofluorane on Wash-out Time in COPD

Anesthesia Clinical Trial

— washout  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209883
• Other study ID #: sevofluorane washout time COPD
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: August 5, 2015
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Duzce University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

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, 

References & Publications (1)

Adanir T, Atay A, Sencan A, Aksun M, Karahan N. Effect of cigarette smoking on the washout time of sevoflurane anesthesia. BMC Anesthesiol. 2010 Jun 22;10:8. doi: 10.1186/1471-2253-10-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	washout time	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	No
Secondary	extubation time	The time which sevoflurane MAC level decrease 1 MAC to extubation	seconds	No

External Links

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