AGC Mode vs Minimal Flow in Breast Surgery

Breast Diseases Clinical Trial

Official title:

Comparison of AGC (Automatic Gas Control) Mode and Manually Controlled Minimal Flow Anesthesia in Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404269
• Other study ID #: 2021/05-12
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: May 2022
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 4, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia; Functional
• Breast Diseases

Intervention

Device:
• AGC mode
Automated Gas Control mode at Maquet FLOW-i anesthesia machine

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of Volatile Agent	Difference of Sevoflurane Consumption between the groups	during the surgery