NCT06055335

Brief Summary

The patients were randomized into two groups medium flow anesthesia (MeFA) and minimal flow anesthesia (MiFA). While MeFA received medium flow anesthesia with 2 lt/min, MiFA received minimal flow anesthesia with 0.5 lt/min fresh gas flow. In both groups dynamic compliance values, peak inspiratory pressure (PIP) values, total inhalation anesthetic drug consumption, total remifentanil drug consumption, duration of anesthesia, and duration of surgery were recorded. The FVC, FEV1, and FEV1/FVC values of the patients in both groups were evaluated and noted 24 hours before the operation, after the operation 2nd, 8th, and 24th hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 14, 2023

Last Update Submit

September 20, 2023

Conditions

Medium Flow AnesthesiaMinimal Flow AnesthesiaPulmonary Function TestCompliance, PatientPeak Inspiratuar Pressure

Outcome Measures

Primary Outcomes (12)

  • Dynamic Compliance assessment

    Dynamic Compliance will be assessed 5th minutes after endotracheal intubation

    5th minutes after endotracheal intubation

  • Dynamic Compliance assessment

    Dynamic Compliance will be assessed 5th minutes after the surgical incision

    5th minutes after surgical incision

  • Dynamic Compliance assessment

    Dynamic Compliance will be assessed 10th minutes after the surgical incision

    10th minutes after surgical incision

  • Dynamic Compliance assessment

    Dynamic Compliance will be assessed 30th minutes after the surgical incision

    30th minutes after surgical incision

  • Dynamic Compliance assessment

    Dynamic Compliance will be assessed 60th minutes after the surgical incision

    60th minutes after surgical incision

  • Dynamic Compliance assessment

    Dynamic Compliance will be assessed immediately after the end of the surgical suturing

    immediately after the end of the surgical suturing

  • Peak inspiratory pressure assessment

    Peak inspiratory pressure will be assessed 5th minutes after endotracheal intubation

    5th minutes after endotracheal intubation

  • Peak inspiratory pressure assessment

    Peak inspiratory pressure will be assessed 5th minutes after the surgical incision

    5th minutes after the surgical incision

  • Peak inspiratory pressure assessment

    Peak inspiratory pressure will be assessed 10th minutes after the surgical incision

    10th minutes after the surgical incision

  • Peak inspiratory pressure assessment

    Peak inspiratory pressure will be assessed 30th minutes after the surgical incision

    30th minutes after the surgical incision

  • Peak inspiratory pressure assessment

    Peak inspiratory pressure will be assessed 60th minutes after the surgical incision

    60th minutes after the surgical incision

  • Peak inspiratory pressure assessment

    Peak inspiratory pressure will be assessed immediately after the end of the surgical suturing

    immediately after the end of the surgical suturing

Secondary Outcomes (12)

  • FEV1 measures assessment

    24 hours before the operation

  • FEV1 measures assessment

    2nd hour after the operation

  • FEV1 measures assessmentt

    8th hour after the operation

  • FEV1 measures assessment

    24th hour after the operation

  • FVC measures assessment

    24 hours before the operation

  • +7 more secondary outcomes

Study Arms (2)

Medium flow anesthesia

EXPERIMENTAL

After reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane.

Other: Medium flow anesthesia

Minimal flow anesthesia

EXPERIMENTAL

After reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane.

Other: Minimal flow anesthesia

Interventions

Medium flow anesthesiaOTHER

Group MeFA; after reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.

Medium flow anesthesia
Minimal flow anesthesiaOTHER

Group MiFA; after reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.

Minimal flow anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • years of age, who will undergo elective laparoscopic cholecystectomy surgery

You may not qualify if:

  • ASA III-IV
  • Smokers
  • Body mass index (BMI) \> 40 kg / m2,
  • Patients with cardiovascular system disease
  • Chronic respiratory diseases,
  • Patients whose pulmonary function tests cannot be applied and who have problems with pulmonary function tests during the examination of the chest disease consultant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erkan Cem ÇELİK

Erzurum, 25080, Turkey (Türkiye)

Location

Related Publications (1)

  • Celik EC, Yayik AM, Aydin ME, Koksal ENM, Disci E, Kerget B, Doymus O, Ahiskalioglu EO, Ahiskalioglu A. Evaluation of lung dynamics and respiratory functions in patients undergoing minimal flow anesthesia: a prospective, randomized controlled trial. Med Gas Res. 2026 Jun 1;16(2):110-115. doi: 10.4103/mgr.MEDGASRES-D-25-00037. Epub 2025 Aug 18.

    PMID: 40826933DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 26, 2023

Study Start

June 2, 2021

Primary Completion

March 25, 2022

Study Completion

April 27, 2022

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

TU(1)