- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05554263
Comparison of Automated Control Anesthesia and Manual Control Anesthesia in Minimal Flow Anesthesia
Comparison of Automated Control Anesthesia and Manual Control Anesthesia Methods İn Minimal Flow Anesthesia in the Mindray A9®
Study Overview
Status
Conditions
Detailed Description
In the manual technique, the inspired and exhaled gas concentrations are regulated by the anesthetists manually by the fresh gas flow during general anaesthesia. When administered manually, low-flow anesthesia requires the attention and time of the anesthesiologist, especially the difference between the gas concentrations set in the anesthesia machine and the respiratory system, and the delay between changes in fresh gas concentrations and the end tidal fraction (EtAA) of the anesthetic agent. The most important risks of manually controlled low-flow anesthesia are hypoxia and awareness that may occur due to low doses of inhaler anesthetic agents.
In the automatic controlled anesthesia technique, it is a method in which the values desired by the anesthetists during general anesthesia are determined at the beginning of anesthesia and automatically adjusted by the anesthesia device without any additional intervention. After intubation, anesthetists set 3 parameters on the anesthesia device: inspiratory or expiratory oxygen fraction (FiO2- End tidal O2 concentration), anesthetic agent concentration (MAC or End-tidal Anesthetic agent concentration) and fresh gas flow amount. With this method, it is aimed to provide safer and more stable anesthesia. In addition, it has been stated in many previous studies that automatic control anesthesia technique reduces anesthetic gas consumption and less anesthesiologist intervention is needed to reach target values.
In our study, we aimed to compare the safety, efficiency and cost aspects of automatic controlled anesthesia and manual control methods in achieving intraoperative target anesthetic and oxygen concentrations. We hypothesized that anesthesia applied with the end-tidal control method would have a lower cost, less workload, and similar anesthetic depth with the manual control method.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sakarya, Turkey, 54100
- Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation
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Sakarya, Turkey, 54100
- Sakarya University Research and Training hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between 18-75 year-old
- ASA 1-3
- Will undergo gynecological operation
- Expected surgery time (>1 hour)
Exclusion Criteria:
❖ BMI >30
- Chronic opioid use
- Contraindication to any of the anesthetic agents to be used
- Neurological disorders
- Surgery lasting <1 hour
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ET-AA
Time Frame: 10 minutes
|
searching the time needed to reach the target end tidal anesthetic agent (ET-AA) concentration and the amount of anesthetic agent consumption
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
target values
Time Frame: 4 hours
|
number of adjustments required to stay within target values and hemodynamic stability
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rezan Şerefoğlu, Sakarya University Research and Training hospital
Publications and helpful links
General Publications
- Tay S, Weinberg L, Peyton P, Story D, Briedis J. Financial and environmental costs of manual versus automated control of end-tidal gas concentrations. Anaesth Intensive Care. 2013 Jan;41(1):95-101. doi: 10.1177/0310057X1304100116.
- Singaravelu S, Barclay P. Automated control of end-tidal inhalation anaesthetic concentration using the GE Aisys Carestation. Br J Anaesth. 2013 Apr;110(4):561-6. doi: 10.1093/bja/aes464. Epub 2013 Jan 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Autocontrolled Anesthesia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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