Clinical trial NCT06759623: Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery
Official title: Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It is known that more or less pronounced impairment of pulmonary function occurs after anesthesia. It has been demonstrated in the postoperative period in both patients undergoing general and regional anesthesia, in patients after intra-abdominal and superficial procedures, in overweight and normal-weight patients. It has also been shown that when general anesthesia is performed with the inhalation anesthetic sevoflurane, there is a slightly smaller reduction in lung function parameters than when only intravenous anesthetics are used.

The purpose of this study is to evaluate lung function before induction and after awakening from general anesthesia depending on the inhalational anesthetic used in obese patients undergoing bariatric surgery


Eligibility criteria: Inclusion Criteria:

* Obese patients qualified for bariatric surgery.

Exclusion Criteria:

* Patients who have absolute contraindications to spirometry testing, i.e:

  * with aneurysms of the aorta or cerebral arteries threatening to rupture, after recent vascular surgery
  * with increased intracranial pressure, after recent intracranial bleeding or head surgery within the cranial cavity
  * after acute conditions within 6 months prior to surgery such as stroke, myocardial infarction, unstable angina, pneumothorax
  * with uncontrolled hypertension
  * after recent eye surgery or a history of retinal detachment
  * with hemoptysis of unknown etiology. And patients unable to perform spirometry testing

Primary outcomes:
measure: Heart rate (HR)
timeFrame: Continuously during whole duration of anesthesia
measure: Pulse oximetry (SpO2)
timeFrame: Continuously during whole duration of anesthesia
measure: End tidal CO2 (etCO2)
timeFrame: Continuously during whole duration of anesthesia
measure: Minimum alveolar concentration (MAC)
timeFrame: Continuously during whole duration of anesthesia
measure: Bispectral index (BIS)
timeFrame: Continuously during whole duration of anesthesia
measure: Train of for (TOF)
timeFrame: Every 2.5 minutes during whole duration of anesthesia
measure: Non invasive blood pressure (NIBP)
timeFrame: Every 5 minutes during whole duration of anesthesia
measure: Forced vital capacity (FVC)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Volume that has been exhaled at the end of the first second of forced expiration (FEV1)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Mid-expiratory flow; the rates at 25% FVC (MEF25)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Mid-expiratory flow; the rates at 25% FVC (MEF50)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Peak expiratory flow (PEF)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Respiratory input impedance (Zrs)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Resistive component (Rrs)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Reactive component (Xrs)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Resonant frequency (Fres)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
measure: Area of reactance (Ax)
timeFrame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: University Clinical Center
Study officials:
References: