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CompletedNCT02209883washoutUpdated Aug 6, 2015

The Effect of Sevofluorane on Wash-out Time in COPD

An observational study in Anesthesia, sponsored by Duzce University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-06.

Sponsored by Duzce University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia

Keywords

  • sevoflurane, anesthesia, washout time,COPD
03

In context

Lead sponsor

Duzce University is the lead sponsor of 76 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cardiac failure
  • Hepatic failure
  • Renal failure
  • Neurologic diseases
  • Endocrine diseases
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: second

Secondary outcomes

  1. extubation time

    The time which sevoflurane MAC level decrease 1 MAC to extubation

    Time frame: seconds

07

Study locations

1 site
  • Duzce Univercity Medical Fauculty
    Düzce, 81620, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 20569431 ↗

Related links

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2014
First posted
Aug 6, 2014
Start
Nov 2012
Primary completionActual
Aug 2015
CompletionActual
Aug 2015
Last update
Aug 6, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02209883
Lead sponsor
Duzce University
Responsible party
Ilknur Suidiye (Assistant profesor, Duzce University) — Principal investigator
First posted
Aug 6, 2014
Start date
Nov 2012
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Aug 6, 2015

Study contacts

Ilknur Suidiye Seker, Asist. prof.
study director · Duzce University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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