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CompletedNCT07248917SEVOMIN-RIRSUpdated Nov 25, 2025

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

An interventional study of Sevoflurane Anesthesia with Minimal-flow and Sevoflurane Anesthesia with Low-flow in Retrograde Intrarenal Surgery (RIRS), Urolithiasis and Minimal-flow Anesthesia, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Retrograde Intrarenal Surgery (RIRS)
  • Urolithiasis
  • Minimal-flow Anesthesia
  • Sevoflurane
  • Anesthetic Consumption
  • Inhalational Anesthesia
  • Anesthesia Depth Monitoring

Keywords

  • minimal-flow anesthesia, low-flow anesthesia, sevoflurane, retrograde intrarenal surgery (RIRS), volatile consumption, environmental sustainability, MAC, BIS
03

In context

Urolithiasis

278 studies on the registry are indexed under Urolithiasis; 70 are open to participants now.

This study's enrollment of 62 is below the median of 100 across 197 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 76 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Minimal-flow Sevoflurane Group

    Participants in this group received general anesthesia using sevoflurane with a fresh gas flow rate reduced to 0.5 L/min after the initial 10 minutes of induction. Anesthesia depth was monitored using BIS, and agent consumption and respiratory parameters were recorded throughout the retrograde intrarenal surgery (RIRS) procedure.

    Drug: Sevoflurane Anesthesia with Minimal-flow

  • Active comparator
    Low-flow Sevoflurane Group

    Participants in this group received general anesthesia using sevoflurane with a consistent 1.0 L/min fresh gas flow during the maintenance phase. BIS monitoring, agent consumption, and respiratory parameters were recorded throughout the retrograde intrarenal surgery (RIRS).

    Drug: Sevoflurane Anesthesia with Low-flow

Interventions

  • DrugSevoflurane Anesthesia with Minimal-flow

    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.

  • DrugSevoflurane Anesthesia with Low-flow

    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.

06

What researchers measure

Primary outcomes

  1. Total Sevoflurane Consumption (mL)

    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.

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

Other outcomes

  1. Time to Reach 1 MAC (minutes)

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

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

  2. Vaporizer Shut-off Time (minutes)

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

    Time frame: Intraoperative

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

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

    Time frame: Throughout surgery

  4. BIS Values During Maintenance (BIS Index Units)

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

    Time frame: Throughout surgery

  5. MAC Values During Maintenance (MAC Units)

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

    Time frame: Throughout surgery

  6. Respiratory Rate (breaths per minute)

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

    Time frame: Throughout surgery

  7. Oxygen Saturation (SpO₂, %)

    Minimum oxygen saturation values recorded intraoperatively to evaluate respiratory safety.

    Time frame: Throughout surgery

07

Study locations

1 site
  • Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences
    Istanbul, 34865, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Our study is: Single-center Non-commercial Conducted as part of a medical specialty thesis There is no stated plan to share anonymized individual-level data beyond what is reported in our thesis or publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07248917
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Umit Yildiz (Medical Doctor in Anesthesiology and Reanimation, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Nov 25, 2025
Start date
Oct 1, 2024
Primary completion
Jun 1, 2025
Completion
Sep 1, 2025
Last update
Nov 25, 2025

Study contacts

UMIT YILDIZ, M.D.
principal investigator · Department of Anesthesiology and Reanimation, Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences, Istanbul, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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