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NCT Number: NCT05554263

Comparison of Automated Control Anesthesia and Manual Control Anesthesia in Minimal Flow Anesthesia

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation, Sakarya, Turkey (Türkiye)

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. target values

    Time frame: 4 hours

    number of adjustments required to stay within target values and hemodynamic stability

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Comparison of Automated Control Anesthesia and Manual Control Anesthesia Methods İn Minimal Flow Anesthesia in the Mindray A9®

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 26, 2022
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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