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

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06055335
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medium Flow Anesthesia; Minimal Flow Anesthesia; Pulmonary Function Test; Compliance, Patient; Peak Inspiratuar Pressure	Other: Medium flow anesthesia; Other: Minimal flow anesthesia	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Screening
• Official Title: EVALUATION OF LUNG DYNAMICS AND RESPIRATORY FUNCTIONS IN PATIENTS APPLIED WITH MINIMAL FLOW ANESTHESIA: A PROSPECTIVE, RANDOMIZED STUDY
• Actual Study Start Date: Jun 2, 2021
• Actual Primary Completion Date: Mar 25, 2022
• Actual Study Completion Date: Apr 27, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Dynamic Compliance assessment [5th minutes after endotracheal intubation]

   Dynamic Compliance will be assessed 5th minutes after endotracheal intubation

2. Dynamic Compliance assessment [5th minutes after surgical incision]

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

3. Dynamic Compliance assessment [10th minutes after surgical incision]

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

4. Dynamic Compliance assessment [30th minutes after surgical incision]

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

5. Dynamic Compliance assessment [60th minutes after surgical incision]

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

6. Dynamic Compliance assessment [immediately after the end of the surgical suturing]

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

7. Peak inspiratory pressure assessment [5th minutes after endotracheal intubation]

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

8. Peak inspiratory pressure assessment [5th minutes after the surgical incision]

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

9. Peak inspiratory pressure assessment [10th minutes after the surgical incision]

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

10. Peak inspiratory pressure assessment [30th minutes after the surgical incision]

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

11. Peak inspiratory pressure assessment [60th minutes after the surgical incision]

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

12. Peak inspiratory pressure assessment [immediately after the end of the surgical suturing]

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

Secondary Outcome Measures

1. FEV1 measures assessment [24 hours before the operation]

   FEV1 measures assessment will be assessed 24 hours before the operation

2. FEV1 measures assessment [2nd hour after the operation]

   FEV1 measures assessment will be assessed 2nd hours after the operation

3. FEV1 measures assessmentt [8th hour after the operation]

   FEV1 measures assessment will be assessed 8th hours after the operation

4. FEV1 measures assessment [24th hour after the operation]

   FEV1 measures assessment will be assessed 24th hours after the operation

5. FVC measures assessment [24 hours before the operation]

   FVC measures assessment will be assessed 24 hours before the operation

6. FVC measures assessment [2nd hour after the operation]

   FVC measures assessment will be assessed 2nd hour after the operation

7. FVC measures assessment [8th hour after the operation]

   FVC measures assessment will be assessed 8th hour after the operation

8. FVC measures assessment [24th hour after the operation]

   FVC measures assessment will be assessed 24th hours after the operation

9. FEV1/FVC measures assessment [24 hours before the operation]

   FEV1/FVC measures assessment will be assessed 24 hours before the operation

10. FEV1/FVC measures assessment [2nd hour after the operation]

    FEV1/FVC measures assessment will be assessed 2nd hour after the operation

11. FEV1/FVC measures assessment [8th hour after the operation]

    FEV1/FVC measures assessment will be assessed 8th hour after the operation

12. FEV1/FVC measures assessment [24th hour after the operation]

    FEV1/FVC measures assessment will be assessed 24th hour after the operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erkan Cem ÇELİK	Erzurum		Turkey	25080

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erkan Cem ÇELİK, Associate Professor, Ataturk University
• ClinicalTrials.gov Identifier: NCT06055335
• Other Study ID Numbers: 2/106 25.03.2021
• First Posted: Sep 26, 2023
• Last Update Posted: Sep 26, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Sep 26, 2023