Volatil Agent ConsumptionNCT05404269
AGC Mode vs Minimal Flow in Breast Surgery
An observational study of Volatil Agent Consumption and Automatic End-tidal Controlled Anesthesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Volatil Agent Consumption, Automatic End-tidal Controlled Anesthesia, Anesthesia; Functional
- What is being tested?
- AGC mode
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 4 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Between 18-65 years, female patients underwent breast surgery
Who may be able to join
- 18-65 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
Who cannot join
- coronary artery disease, CHF
- pregnancy or breastfeeding women
- decompensated diabetes mellitus
- kidney or liver failure
- chronic obstructive pulmonary disease
- opioid sensitivity
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Comparison of AGC (Automatic Gas Control) Mode and Manually Controlled Minimal Flow Anesthesia in Breast Surgery
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
Read the detailed description
Modern anesthesia machines use circular systems in which ventilated gas re-circulates to a certain degree and is therefore reused, preserving temperature, and humidity. The rebreathing fraction is increased by a reduction in fresh gas flow, which leads to a considerable decrease in consumption of fresh gas and volatile anesthetics, resulting in reductions in cost and atmospheric pollution. In a closed ventilation system, only the patient's requirements for oxygen and anesthetic agents are supplemented. A fresh gas flow-rate of 0.5 l/min is defined as the minimal-flow technique. The oxygen and anesthetic gas titration can be manually controlled by the anesthetist. To assure safe and appropriate anesthesia, manually controlled anesthesia requires constant monitoring and numerous adjustments to the gas dosage by the anesthetist, especially for low- and minimalflow anesthesia. Oxygen flow and volatile anesthetics can also be automatically controlled by anesthesia machines using end-tidal control (such as AGC mode of Maquet FLOW-i anesthesia machine), which ensures constant end-tidal concentration of oxygen and anesthetic gas via feedback and continuous automatic adjustment mechanisms. Anesthesiologists needing to make fewer interventions during a case may have clinical importance in terms of distraction, record keeping and patient safety. In addition to this advantage, we wanted to compare the AGC mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia.
- Conditions
- Volatil Agent Consumption, Automatic End-tidal Controlled Anesthesia, Anesthesia; Functional, Breast Diseases
- Being tested
- AGC mode
- Keywords
- anesthesia machine, sevoflurane, minimal fresh gas flow, breast surgery, AGC mode
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGC modeDevice
Automated Gas Control mode at Maquet FLOW-i anesthesia machine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of Volatile Agent
Difference of Sevoflurane Consumption between the groups
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start15 Mar 2021
- Primary completion15 Mar 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volatil Agent ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Çeviker, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404269
- Sponsor's protocol ID
- 2021/05-12
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AGC (Automatic Gas Control) Mode and Manually Controlled Minimal Flow Anesthesia in Breast Surgery
- ClinicalTrials.gov ID
- NCT05404269
- Acronym / sponsor ID
- 2021/05-12
- Conditions
- Volatil Agent Consumption, Automatic End-tidal Controlled Anesthesia, Anesthesia; Functional, Breast Diseases
- Keywords
- anesthesia machine, sevoflurane, minimal fresh gas flow, breast surgery, AGC mode
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Modern anesthesia machines use circular systems in which ventilated gas re-circulates to a certain degree and is therefore reused, preserving temperature, and humidity. The rebreathing fraction is increased by a reduction in fresh gas flow, which leads to a considerable decrease in consumption of fresh gas and volatile anesthetics, resulting in reductions in cost and atmospheric pollution. In a closed ventilation system, only the patient's requirements for oxygen and anesthetic agents are supplemented. A fresh gas flow-rate of 0.5 l/min is defined as the minimal-flow technique. The oxygen and anesthetic gas titration can be manually controlled by the anesthetist. To assure safe and appropriate anesthesia, manually controlled anesthesia requires constant monitoring and numerous adjustments to the gas dosage by the anesthetist, especially for low- and minimalflow anesthesia. Oxygen flow and volatile anesthetics can also be automatically controlled by anesthesia machines using end-tidal control (such as AGC mode of Maquet FLOW-i anesthesia machine), which ensures constant end-tidal concentration of oxygen and anesthetic gas via feedback and continuous automatic adjustment mechanisms. Anesthesiologists needing to make fewer interventions during a case may have clinical importance in terms of distraction, record keeping and patient safety. In addition to this advantage, we wanted to compare the AGC mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group AGC | – | Device: AGC modeThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Between 18-65 years, female patients underwent breast surgery
Key inclusion criteria (6 listed)
- 18-65 years
- undergoing breast surgery
- ASA physical status I-II
- female
- operation lasting at least 1 hour
Key exclusion criteria (13 listed)
- coronary artery disease, CHF
- pregnancy or breastfeeding women
- decompensated diabetes mellitus
- kidney or liver failure
- chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGC modeAutomated Gas Control mode at Maquet FLOW-i anesthesia machine | Device | Group AGC |
Primary outcome
Consumption of Volatile Agent
Time frame: during the surgery
Difference of Sevoflurane Consumption between the groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volatil Agent Consumption and Automatic End-tidal Controlled Anesthesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of Volatile Agent (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022; AzTrials last refreshed its copy on 27 Oct 2026.