NCT05404269

Brief Summary

The aim of this study was to compare the AGC mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

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

March 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 30, 2022

Last Update Submit

May 30, 2022

Conditions

Keywords

anesthesia machinesevofluraneminimal fresh gas flowbreast surgeryAGC mode

Outcome Measures

Primary Outcomes (1)

  • Consumption of Volatile Agent

    Difference of Sevoflurane Consumption between the groups

    during the surgery

Study Arms (3)

Group AGC

The FLOW-i anesthesia machine (Maquet, Solna, Sweden) can be equipped with automated gas control (AGC), an automated low flow tool with target control of the inspired oxygen concentration (FIO2) and end-expired concentration (FA) of a potent inhaled anesthetic. İnitially before induction, we set the minimal fresh gas flow to 0.5 L min-1 and target end-expired agent concentration for 1 MAC (minimal alveolar concentration). Shortly after intubation of the patient, we switched to AGC mode.

Device: AGC mode

Group Minimal Flow

İn this group; following intubation, we set the fresh gas flow to 4 L min-1 and than we readjusted fresh gas flow manually to 0.5 L min-1 after sevoflurane concentration reaching to 1 MAC.

Group Medium Flow

İn this group; following intubation, we set the fresh gas flow to 4 L min-1 and than we readjusted fresh gas flow manually to 2 L min-1 after sevoflurane concentration reaching to 1 MAC.

Interventions

AGC modeDEVICE

Automated Gas Control mode at Maquet FLOW-i anesthesia machine

Group AGC

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between 18-65 years, female patients underwent breast surgery

You may qualify if:

  • years
  • undergoing breast surgery
  • ASA physical status I-II
  • female
  • operation lasting at least 1 hour
  • those who agreed to volunteer for the study with an informed consent form

You may not qualify if:

  • coronary artery disease, CHF
  • pregnancy or breastfeeding women
  • decompensated diabetes mellitus
  • kidney or liver failure
  • chronic obstructive pulmonary disease
  • opioid sensitivity
  • history of malignant hyperthermia
  • history of smoking
  • alcohol or drug addiction
  • significant anemia
  • sepsis
  • BMI \>35
  • patients with allergies to the drugs used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 3, 2022

Study Start

March 15, 2021

Primary Completion

March 15, 2022

Study Completion

April 4, 2022

Last Updated

June 3, 2022

Record last verified: 2022-05

Locations