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CompletedNCT05554263Updated Aug 25, 2023

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

An observational study in Anesthesia, Sevoflurane and Monitoring, sponsored by Sakarya University. Completed at 2 sites in Turkey. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Sakarya University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia
  • Sevoflurane
  • Monitoring
03

In context

Lead sponsor

Sakarya University is the lead sponsor of 176 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Between 18-75 year-old
  • ASA 1-3
  • Will undergo gynecological operation
  • Expected surgery time (>1 hour)

Exclusion criteria

Exclusion Criteria:

  • ❖ BMI >30

    • Chronic opioid use
    • Contraindication to any of the anesthetic agents to be used
    • Neurological disorders
    • Surgery lasting \<1 hour
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. ET-AA

    searching the time needed to reach the target end tidal anesthetic agent (ET-AA) concentration and the amount of anesthetic agent consumption

    Time frame: 10 minutes

Secondary outcomes

  1. target values

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

    Time frame: 4 hours

07

Study locations

2 sites
  • Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation
    Sakarya, 54100, Turkey
  • Sakarya University Research and Training hospital
    Sakarya, 54100, Turkey
08

References and documents

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. PubMed 23362897 ↗
  • 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. PubMed 23293274 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05554263
Lead sponsor
Sakarya University
Responsible party
Rezan Şerefoğlu (Research assistant, Sakarya University) — Principal investigator
First posted
Sep 26, 2022
Start date
Sep 1, 2022
Primary completion
Sep 1, 2022
Completion
May 1, 2023
Last update
Aug 25, 2023

Study contacts

Rezan Şerefoğlu
principal investigator · Sakarya University Research And Training hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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