- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03955406
Low Flow Anesthesia Without Initial High Flow Phase
July 9, 2019 updated by: MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University
Comparison of Low Flow Anesthesia With and Without Initial High Flow Phase
The aim of the study is to compare the effectiveness of conventional low flow anesthesia (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas flow rate (1L/min).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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
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In The USA Or Canada, Please Select...
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Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
- Kahramanmaras Sutcu Imam University
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA 1-3
- scheduled for surgery under general anesthesia with endotracheal intubation
Exclusion Criteria:
- hemodynamic instability
- emergency cases
- expected anesthesia duration < 60 min
- patient refusal
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional group
After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 6% with fresh gas flow rate 4 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 1% higher value than the EtAA concentration required to achieve 0.7 MAC.
And after 10 minutes fresh gas flow rate will be reduced to 1L/min.
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During the initial wash-in period 4 L/min Fresh gas flow will be used.
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Active Comparator: Fixed Fresh Gas Flow Rate group
After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 18% with fresh gas flow rate 1 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 2% higher value than the EtAA concentration required to achieve 0.7 MAC.
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Fresh gas flow rate will be 1 L/min throughout the procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The time required to reach 0.7 MAC
Time Frame: perioperative
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perioperative
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number of adjustments made to the vaporizer settings
Time Frame: perioperative
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MAC will be held between 0.6-0.8 with adjustments at the vaporizer
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perioperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anesthetic agent consumption
Time Frame: perioperative
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desfluane consumption at the first hour and at the end of the surgery wil be recorded
|
perioperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
May 22, 2019
Primary Completion (Actual)
July 2, 2019
Study Completion (Actual)
July 2, 2019
Study Registration Dates
First Submitted
May 16, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 20, 2019
Study Record Updates
Last Update Posted (Actual)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 9, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSU 2017-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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