Clinical Trials Directory

Trials / Completed

CompletedNCT07465146

Effects of Minimal and Metabolic Flow Sevoflurane Anesthesia in Gynecological Surgery Patients

Comparative Analysis of Sevoflurane-Based Minimal and Metabolic Flow Anaesthesia: A Prospective Randomized Study in a Gynecological Surgery Patient Cohort

Status
Completed
Phase
Study type
Observational
Enrollment
97 (actual)
Sponsor
Baskent University · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to observe the effects of minimal and metabolically required basal anesthetic gas flow rates delivered by the anesthesia workstation under general anesthesia on body temperature, blood pressure, and heart rate during surgery. It also aims to evaluate the impact of reducing excessive delivery of anesthetic gases, air, and oxygen beyond the patient's physiological needs during general anesthesia on minimizing the harmful effects of anesthetic gases on the environment, climate, and global warming, as well as on contributing positively to hospital costs.

Detailed description

This prospective randomized study will be conducted in adult female patients undergoing elective gynecological surgery under general anesthesia. Following standard intravenous induction and endotracheal intubation, anesthesia will be maintained with sevoflurane using an advanced anesthesia workstation capable of delivering minimal and metabolic fresh gas flow rates. After achieving the target anesthetic depth guided by minimum alveolar concentration (MAC) and MAC Brain monitoring, patients will be randomized to receive either minimal-flow (0.5 L/min) or metabolic-flow (0.3 L/min) fresh gas anesthesia. Randomization will be performed using an internet-based randomization tool. Standard intraoperative monitoring will be applied in all patients, including electrocardiography, non-invasive blood pressure monitoring, pulse oximetry, capnography, anesthetic gas analysis, and esophageal temperature monitoring. Hemodynamic and respiratory parameters will be recorded at predefined time intervals throughout surgery. Sevoflurane consumption will be automatically calculated by the anesthesia workstation. At the end of surgery, fresh gas flow will be increased to eliminate residual anesthetic gases, and patients will be extubated according to standard clinical criteria. Postoperative monitoring will continue in the post-anesthesia care unit. The total study duration for each participant includes the intraoperative period and approximately 30 minutes of postoperative monitoring.

Conditions

Interventions

TypeNameDescription
PROCEDURELow Flow AnesthesiaAdjustment of fresh gas flow rates during general anesthesia using a modern anesthesia workstation (Getinge Flow-C). Patients will be randomized to receive anesthesia with either minimal flow (0.5 L/min) or metabolic flow (0.3 L/min). All other anesthetic agents and monitoring parameters will remain standardized according to institutional protocols.

Timeline

Start date
2024-11-05
Primary completion
2025-02-05
Completion
2025-02-05
First posted
2026-03-11
Last updated
2026-03-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07465146. Inclusion in this directory is not an endorsement.