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Evaluation of Sevoflurane Consumption During Initial Phase of Minimal-Flow Anesthesia in Retrograde Intrarenal Surgery (SEVOMIN-RIRS)

R

Republic of Turkey Ministry of Health

Status

Completed

Conditions

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

Treatments

Drug: Sevoflurane Anesthesia with Low-flow
Drug: Sevoflurane Anesthesia with Minimal-flow

Study type

Interventional

Funder types

Other

Identifiers

NCT07248917
2024/16/925 (Other Identifier)
KLKSH-ANES-SEVOMIN-RIRS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Minimal-flow Sevoflurane Group
Experimental group
Description:
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.
Treatment:
Drug: Sevoflurane Anesthesia with Minimal-flow
Low-flow Sevoflurane Group
Active Comparator group
Description:
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).
Treatment:
Drug: Sevoflurane Anesthesia with Low-flow

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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