Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery

NCT06759623 · tracked via the Priya Life Science Poland tracker

Sponsor

Medical University of Gdansk

Phase

Not applicable

Started

2025-01-08

Last updated

2025-01-06

Condition(s) studied

Obesity and Obesity-related Medical Conditions

Investigational drug(s) / intervention(s)

Different drug type for conduction of general anesthesia

Different drug type for conduction of general anesthesia: Patients will be randomly divided into two groups: patients for whom general anesthesia will be performed with sevoflurane and patients for whom general anesthesia will be performed with desflurane.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Heart rate (HR) — Continuously during whole duration of anesthesia
HR will be measured by ecg in beat per minute
Pulse oximetry (SpO2) — Continuously during whole duration of anesthesia
SpO2 will be measured by light spectrometry percutaneous sensor in %
End tidal CO2 (etCO2) — Continuously during whole duration of anesthesia
etCO2 will be measured by capnography with infrared radiation sensor in mmHg. Sensor will be attached to breathing circuit.
Minimum alveolar concentration (MAC) — Continuously during whole duration of anesthesia
MAC will be measured based on exhaled anesthetic gas concentration in absolute numbers
Bispectral index (BIS) — Continuously during whole duration of anesthesia
BIS will be measured with Covidien BIS monitoring system in absolute numbers
Train of for (TOF) — Every 2.5 minutes during whole duration of anesthesia
TOF will be measured in absolute numbers
Non invasive blood pressure (NIBP) — Every 5 minutes during whole duration of anesthesia
NIBP will be measured with oscillometric method in mmHG
Forced vital capacity (FVC) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
FVC will be measured with spirometry
Volume that has been exhaled at the end of the first second of forced expiration (FEV1) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
FEV1 will be measured with spirometry
Mid-expiratory flow; the rates at 25% FVC (MEF25) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
MEF25 will be measured with spirometry
Mid-expiratory flow; the rates at 25% FVC (MEF50) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
MEF50 will be measured with spirometry
Peak expiratory flow (PEF) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
PEF will be measured with spirometry
Respiratory input impedance (Zrs) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Zrs will be measured with impulsed oscillometry
Resistive component (Rrs) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Rrs will be measured with impulsed oscillometry
Reactive component (Xrs) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Xrs will be measured with impulsed oscillometry
Resonant frequency (Fres) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Fres will be measured with impulsed oscillometry
Area of reactance (Ax) — 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Ax will be measured with impulsed oscillometry

Trial sites (1)

Facility	City	Region	Status
University Clinical Center	Gdansk	Poland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06759623 on ClinicalTrials.gov ↗ ← All trials in Poland