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

August 23, 2023 updated by: Rezan Şerefoğlu, Sakarya University

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

80

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

      • Sakarya, Turkey, 54100
        • Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation
      • Sakarya, Turkey, 54100
        • Sakarya University Research and Training hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective gynecological operation under general anesthesia will be included in the study.

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

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

  • 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
10 minutes

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rezan Şerefoğlu, Sakarya University Research and Training hospital

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.

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)

September 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

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

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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