Clinical Trials Directory

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CompletedNCT07248917

Evaluation of Sevoflurane Consumption During Initial Phase of Minimal-Flow Anesthesia in Retrograde Intrarenal Surgery

A Comparative Evaluation of Sevoflurane Consumption and Anesthetic Depth During the Initial Phase of Minimal-Flow Versus Low-Flow Anesthesia in Patients Undergoing Retrograde Intrarenal Surgery (RIRS)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This study aimed to compare the effects of minimal-flow (0.5 L/min) and low-flow (1.0 L/min) sevoflurane anesthesia on agent consumption, anesthetic depth, and cardiorespiratory safety during retrograde intrarenal surgery (RIRS). A total of 62 adult patients undergoing elective RIRS were enrolled in this single-center interventional trial. Patients were divided into two groups based on the fresh gas flow rate used during the maintenance phase of anesthesia. The primary outcome was total sevoflurane consumption at the end of anesthesia. Secondary outcomes included time to reach 1 minimum alveolar concentration (MAC), vaporizer shut-off time, BIS values, MAC levels, and respiratory parameters. The study found that minimal-flow anesthesia was as effective and safe as low-flow anesthesia, with lower agent consumption and no adverse effects on hemodynamic or respiratory parameters. These findings support the use of minimal-flow anesthesia for improved cost-efficiency and environmental sustainability.

Detailed description

This prospective, single-center, interventional study was designed to evaluate and compare the effects of minimal-flow and low-flow anesthesia on sevoflurane consumption, anesthetic depth, and respiratory parameters during retrograde intrarenal surgery (RIRS). After obtaining ethics committee approval (Decision No: 2024/16/925, Date: 17.09.2024), a total of 62 adult patients undergoing elective RIRS under general anesthesia were enrolled and divided into two groups based on the fresh gas flow rate used during the maintenance phase of anesthesia. In Group 1 (Minimal-flow group), the fresh gas flow was reduced to 0.5 L/min after the initial 10 minutes of anesthesia. In Group 2 (Low-flow group), a 1.0 L/min flow rate was maintained. Both groups received the same induction and maintenance protocols with sevoflurane, and depth of anesthesia was monitored via BIS (Bispectral Index). Key variables measured included the total amount of sevoflurane consumed (mL), the time to reach 1 MAC, the vaporizer shut-off time, intraoperative BIS and MAC values, EtCO₂, and respiratory rate. Safety outcomes such as hemodynamic stability and desaturation were also recorded. The primary outcome was total sevoflurane consumption. Secondary outcomes included anesthetic depth consistency (BIS/MAC), respiratory parameters, and time-based metrics. Statistical analysis revealed that minimal-flow anesthesia significantly reduced sevoflurane usage without compromising patient safety or anesthetic depth. The results support the clinical use of minimal-flow anesthesia as a safe, cost-effective, and environmentally favorable alternative to low-flow techniques in selected urological procedures.

Conditions

Interventions

TypeNameDescription
DRUGSevoflurane Anesthesia with Minimal-flowPatients received general anesthesia with sevoflurane. After induction, the fresh gas flow rate was reduced to 0.5 L/min during the maintenance phase of anesthesia for retrograde intrarenal surgery (RIRS). Agent consumption and anesthetic depth (via BIS and MAC) were monitored.
DRUGSevoflurane Anesthesia with Low-flowPatients received general anesthesia with sevoflurane. A fresh gas flow rate of 1.0 L/min was maintained during the maintenance phase of anesthesia for retrograde intrarenal surgery (RIRS). BIS, MAC, and respiratory parameters were recorded.

Timeline

Start date
2024-10-01
Primary completion
2025-06-01
Completion
2025-09-01
First posted
2025-11-25
Last updated
2025-11-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07248917. Inclusion in this directory is not an endorsement.