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Clinical Trials/NCT06759623
NCT06759623
Recruiting
Not Applicable

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

Medical University of Gdansk1 site in 1 country100 target enrollmentJanuary 8, 2025

Overview

Phase
Not Applicable
Intervention
Different drug type for conduction of general anesthesia
Conditions
Obesity and Obesity-related Medical Conditions
Sponsor
Medical University of Gdansk
Enrollment
100
Locations
1
Primary Endpoint
Pulse oximetry (SpO2)
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
January 8, 2025
End Date
April 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Radosław Owczuk

Prof. dr hab.

Medical University of Gdansk

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

Arms & Interventions

General anesthesia with desflurane

Patients undergoing anesthesia for bariatric surgery with desflurane as a volatile agent.

Intervention: Different drug type for conduction of general anesthesia

General anesthesia with sevoflurane

Patients undergoing anesthesia for bariatric surgery with sevoflurane as a volatile agent.

Intervention: Different drug type for conduction of general anesthesia

Outcomes

Primary Outcomes

Pulse oximetry (SpO2)

Time Frame: Continuously during whole duration of anesthesia

SpO2 will be measured by light spectrometry percutaneous sensor in %

Heart rate (HR)

Time Frame: Continuously during whole duration of anesthesia

HR will be measured by ecg in beat per minute

End tidal CO2 (etCO2)

Time Frame: 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.

Area of reactance (Ax)

Time Frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia

Ax will be measured with impulsed oscillometry

Minimum alveolar concentration (MAC)

Time Frame: Continuously during whole duration of anesthesia

MAC will be measured based on exhaled anesthetic gas concentration in absolute numbers

Bispectral index (BIS)

Time Frame: Continuously during whole duration of anesthesia

BIS will be measured with Covidien BIS monitoring system in absolute numbers

Forced vital capacity (FVC)

Time Frame: 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)

Time Frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia

FEV1 will be measured with spirometry

Train of for (TOF)

Time Frame: Every 2.5 minutes during whole duration of anesthesia

TOF will be measured in absolute numbers

Non invasive blood pressure (NIBP)

Time Frame: Every 5 minutes during whole duration of anesthesia

NIBP will be measured with oscillometric method in mmHG

Mid-expiratory flow; the rates at 25% FVC (MEF25)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia

Fres will be measured with impulsed oscillometry

Study Sites (1)

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