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

Compliance, Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06055335
• Other study ID #: 2/106 25.03.2021
• Status: Completed
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: April 27, 2022

Study information

• Verified date: September 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 27, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient
• Pulmonary Function Test

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Erkan Cem ÇELIK	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Compliance assessment	Dynamic Compliance will be assessed 5th minutes after endotracheal intubation	5th minutes after endotracheal intubation
Primary	Dynamic Compliance assessment	Dynamic Compliance will be assessed 5th minutes after the surgical incision	5th minutes after surgical incision
Primary	Dynamic Compliance assessment	Dynamic Compliance will be assessed 10th minutes after the surgical incision	10th minutes after surgical incision
Primary	Dynamic Compliance assessment	Dynamic Compliance will be assessed 30th minutes after the surgical incision	30th minutes after surgical incision
Primary	Dynamic Compliance assessment	Dynamic Compliance will be assessed 60th minutes after the surgical incision	60th minutes after surgical incision
Primary	Dynamic Compliance assessment	Dynamic Compliance will be assessed immediately after the end of the surgical suturing	immediately after the end of the surgical suturing
Primary	Peak inspiratory pressure assessment	Peak inspiratory pressure will be assessed 5th minutes after endotracheal intubation	5th minutes after endotracheal intubation
Primary	Peak inspiratory pressure assessment	Peak inspiratory pressure will be assessed 5th minutes after the surgical incision	5th minutes after the surgical incision
Primary	Peak inspiratory pressure assessment	Peak inspiratory pressure will be assessed 10th minutes after the surgical incision	10th minutes after the surgical incision
Primary	Peak inspiratory pressure assessment	Peak inspiratory pressure will be assessed 30th minutes after the surgical incision	30th minutes after the surgical incision
Primary	Peak inspiratory pressure assessment	Peak inspiratory pressure will be assessed 60th minutes after the surgical incision	60th minutes after the surgical incision
Primary	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	FEV1 measures assessment	FEV1 measures assessment will be assessed 24 hours before the operation	24 hours before the operation
Secondary	FEV1 measures assessment	FEV1 measures assessment will be assessed 2nd hours after the operation	2nd hour after the operation
Secondary	FEV1 measures assessmentt	FEV1 measures assessment will be assessed 8th hours after the operation	8th hour after the operation
Secondary	FEV1 measures assessment	FEV1 measures assessment will be assessed 24th hours after the operation	24th hour after the operation
Secondary	FVC measures assessment	FVC measures assessment will be assessed 24 hours before the operation	24 hours before the operation
Secondary	FVC measures assessment	FVC measures assessment will be assessed 2nd hour after the operation	2nd hour after the operation
Secondary	FVC measures assessment	FVC measures assessment will be assessed 8th hour after the operation	8th hour after the operation
Secondary	FVC measures assessment	FVC measures assessment will be assessed 24th hours after the operation	24th hour after the operation
Secondary	FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 24 hours before the operation	24 hours before the operation
Secondary	FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 2nd hour after the operation	2nd hour after the operation
Secondary	FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 8th hour after the operation	8th hour after the operation
Secondary	FEV1/FVC measures assessment	FEV1/FVC measures assessment will be assessed 24th hour after the operation	24th hour after the operation