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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05554263
Other study ID # Autocontrolled Anesthesia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date May 1, 2023

Study information

Verified date August 2023
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

With the introduction of technology into our lives, we come across two different anesthesia management modules in anesthesia machines. The first of these is the traditional method, the manual controlled anesthesia technique; the other is the automatic controlled anesthesia technique. In our daily practice, both anesthesia techniques can be used in patients who have undergone general anesthesia. These two techniques can be used in both high-flow anesthesia and low-flow anesthesia applications.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation Sakarya
Turkey Sakarya University Research and Training hospital Sakarya

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ET-AA searching the time needed to reach the target end tidal anesthetic agent (ET-AA) concentration and the amount of anesthetic agent consumption 10 minutes
Secondary target values number of adjustments required to stay within target values and hemodynamic stability 4 hours
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