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

Not Applicable

Recruiting

• Conditions: Obesity and Obesity-related Medical Conditions
• Interventions: Drug: Different drug type for conduction of general anesthesia

• Registration Number: NCT06759623
• Lead Sponsor: Medical University of Gdansk

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-01-08
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia with desflurane	Different drug type for conduction of general anesthesia	Patients undergoing anesthesia for bariatric surgery with desflurane as a volatile agent.
General anesthesia with sevoflurane	Different drug type for conduction of general anesthesia	Patients undergoing anesthesia for bariatric surgery with sevoflurane as a volatile agent.

Primary Outcome Measures

Name	Time	Method
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.
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
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
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
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
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

Trial Locations

Locations (1)

University Clinical Center; 🇵🇱 Gdansk, Poland