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

Sponsor
Sakarya University (Other)
Overall Status
Completed
CT.gov ID
NCT05554263
Collaborator
(none)
80
2
4.9
40
8.1

Study Details

Study Description

Brief Summary

IWith 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Automated Control Anesthesia and Manual Control Anesthesia Methods İn Minimal Flow Anesthesia in the Mindray A9®
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Apr 1, 2022
    Actual Study Completion Date :
    May 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. ET-AA [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 Outcome Measures

    1. target values [4 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • Between 18-75 year-old

    • ASA 1-3

    • Will undergo gynecological oncology 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation Sakarya Turkey 54100
    2 Sakarya University Research and Training hospital Sakarya Turkey 54100

    Sponsors and Collaborators

    • Sakarya University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rezan Şerefoğlu, Research assistant, Sakarya University
    ClinicalTrials.gov Identifier:
    NCT05554263
    Other Study ID Numbers:
    • Autocontrolled Anesthesia
    First Posted:
    Sep 26, 2022
    Last Update Posted:
    Nov 17, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 17, 2022