Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06759623

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Different drug type for conduction of general anesthesia

Drug

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.

Primary outcomes

  1. Heart rate (HR)

    Time frame: Continuously during whole duration of anesthesia

    HR will be measured by ecg in beat per minute

  2. Pulse oximetry (SpO2)

    Time frame: Continuously during whole duration of anesthesia

    SpO2 will be measured by light spectrometry percutaneous sensor in %

  3. 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.

  4. 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

  5. Bispectral index (BIS)

    Time frame: Continuously during whole duration of anesthesia

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

  6. Train of for (TOF)

    Time frame: Every 2.5 minutes during whole duration of anesthesia

    TOF will be measured in absolute numbers

  7. Non invasive blood pressure (NIBP)

    Time frame: Every 5 minutes during whole duration of anesthesia

    NIBP will be measured with oscillometric method in mmHG

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Karolina Obara, MD

CONTACT

[email protected]

0048 58 349 32 80

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.