NCT05554263

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

September 21, 2022

Last Update Submit

August 23, 2023

Conditions

Outcome Measures

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

    10 minutes

Secondary Outcomes (1)

  • target values

    4 hours

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients scheduled for elective gynecological oncology operation under general anesthesia will be included in the study.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • ❖ BMI \>30
  • Chronic opioid use
  • Contraindication to any of the anesthetic agents to be used
  • Neurological disorders
  • Surgery lasting \<1 hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sakarya University Medicine Faculty Department of Anaesthesiaology and Reanimation

Sakarya, 54100, Turkey (Türkiye)

Location

Sakarya University Research and Training hospital

Sakarya, 54100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Rezan Şerefoğlu

    Sakarya University Research And Training hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2022

Study Completion

May 1, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations