Assessing Lung Dynamics and Respiratory Functions in Minimal Flow Anesthesia: A Prospective Study

EVALUATION OF LUNG DYNAMICS AND RESPIRATORY FUNCTIONS IN PATIENTS APPLIED WITH MINIMAL FLOW ANESTHESIA: A PROSPECTIVE, RANDOMIZED STUDY

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.

Study Overview

• Status: Completed
• Conditions: Compliance, Patient; Pulmonary Function Test; Minimal Flow Anesthesia; Medium Flow Anesthesia; Peak Inspiratuar Pressure
• Intervention / Treatment: Other: Medium flow anesthesia; Other: Minimal flow anesthesia

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25080
    • Erkan Cem ÇELİK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-II
• 18-65 years of age, who will undergo elective laparoscopic cholecystectomy surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medium flow anesthesia; 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; 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.
Experimental: Minimal flow anesthesia; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 measures assessment	FEV1 measures assessment will be assessed 24 hours before the operation	24 hours before the operation
FEV1 measures assessment	FEV1 measures assessment will be assessed 2nd hours after the operation	2nd hour after the operation
FEV1 measures assessmentt	FEV1 measures assessment will be assessed 8th hours after the operation	8th hour after the operation
FEV1 measures assessment	FEV1 measures assessment will be assessed 24th hours after the operation	24th hour after the operation
FVC measures assessment	FVC measures assessment will be assessed 24 hours before the operation	24 hours before the operation
FVC measures assessment	FVC measures assessment will be assessed 2nd hour after the operation	2nd hour after the operation
FVC measures assessment	FVC measures assessment will be assessed 8th hour after the operation	8th hour after the operation
FVC measures assessment	FVC measures assessment will be assessed 24th hours after the operation	24th hour after the operation
FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 24 hours before the operation	24 hours before the operation
FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 2nd hour after the operation	2nd hour after the operation
FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 8th hour after the operation	8th hour after the operation
FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 24th hour after the operation	24th hour after the operation

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2/106 25.03.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No