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Recruiting NCT06759623

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

No phase Interventional Obesity and Obesity-related Medical Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Different drug type for conduction of general anesthesia.
Who it may be relevant to
Registry conditions: Obesity and Obesity-related Medical Conditions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug 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.

Primary outcome measures

  • Heart rate (HR) [Time frame: Continuously during whole duration of anesthesia]
  • Pulse oximetry (SpO2) [Time frame: Continuously during whole duration of anesthesia]
  • End tidal CO2 (etCO2) [Time frame: Continuously during whole duration of anesthesia]
  • Minimum alveolar concentration (MAC) [Time frame: Continuously during whole duration of anesthesia]
  • Bispectral index (BIS) [Time frame: Continuously during whole duration of anesthesia]
  • Train of for (TOF) [Time frame: Every 2.5 minutes during whole duration of anesthesia]
  • Non invasive blood pressure (NIBP) [Time frame: Every 5 minutes during whole duration of anesthesia]
  • Forced vital capacity (FVC) [Time frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia]
  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Poland · 1 center
  • University Clinical Center — Gdansk

Identifiers

NCT: NCT06759623 · KO_bariatria

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗