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NCT Number: NCT07248917

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 65 years

ASA (American Society of Anesthesiologists) Physical Status I or II

Scheduled to undergo elective retrograde intrarenal surgery (RIRS) under general anesthesia

Provided written informed consent

Able to cooperate with preoperative evaluation procedures

Exclusion criteria

  • ASA Physical Status III or higher

History of respiratory disease (e.g., asthma, COPD, restrictive lung disease)

Known hepatic or renal dysfunction

Neurological or psychiatric disorders that may affect BIS monitoring or anesthetic response

Known allergy or hypersensitivity to sevoflurane or other volatile anesthetics

Pregnancy or breastfeeding

Obesity (BMI > 30 kg/m²)

Anticipated difficult airway or history of intubation complications

Participation in another clinical trial within the past 30 days

Treatment and study plan

Sevoflurane Anesthesia with Minimal-flow

Drug

Patients 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.

Sevoflurane Anesthesia with Low-flow

Drug

Patients 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.

Primary outcomes

  1. Total Sevoflurane Consumption (mL)

    Time frame: End of surgery (approximately 60-90 minutes after anesthesia induction)

    Total volume of sevoflurane (in milliliters) used during the maintenance phase of general anesthesia, calculated automatically by the anesthesia machine and recorded at the end of surgery.

Other outcomes

  1. Time to Reach 1 MAC (minutes)

    Time frame: Intraoperative (within first 10 minutes of anesthesia)

    Time in minutes from anesthesia induction to reaching 1 Minimum Alveolar Concentration (MAC) of sevoflurane, as recorded by the anesthesia machine.

  2. Vaporizer Shut-off Time (minutes)

    Time frame: Intraoperative

    Time in minutes from the start of surgery to the moment the sevoflurane vaporizer was turned off.

  3. End-Tidal CO₂ (EtCO₂) Levels (mmHg)

    Time frame: Throughout surgery

    Mean and peak end-tidal CO₂ levels measured intraoperatively at 10-minute intervals.

  4. BIS Values During Maintenance (BIS Index Units)

    Time frame: Throughout surgery

    Bispectral Index values recorded at 10-minute intervals during the maintenance phase of anesthesia to assess anesthetic depth.

  5. MAC Values During Maintenance (MAC Units)

    Time frame: Throughout surgery

    MAC values recorded during anesthesia maintenance to assess depth and consistency of volatile agent effect.

  6. Respiratory Rate (breaths per minute)

    Time frame: Throughout surgery

    Intraoperative respiratory rates monitored and recorded to assess ventilatory response under different flow settings.

  7. Oxygen Saturation (SpO₂, %)

    Time frame: Throughout surgery

    Minimum oxygen saturation values recorded intraoperatively to evaluate respiratory safety.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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)

Acronym: SEVOMIN-RIRS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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