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

Study Overview

• Status: Recruiting
• Conditions: Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Drug: Different drug type for conduction of general anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karolina Obara, MD; Phone Number: 0048 58 349 32 80; Email: kobara@uck.gda.pl

Study Locations

• Poland
  • Gdansk, Poland
    • Recruiting
    • University Clinical Center
    • Contact: Karolina Obara, MD; Phone Number: 0048 58 349 32 80; Email: kobara@uck.gda.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General anesthesia with desflurane; Patients undergoing anesthesia for bariatric surgery with desflurane as a volatile agent.	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.
Experimental: General anesthesia with sevoflurane; Patients undergoing anesthesia for bariatric surgery with sevoflurane as a volatile agent.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (Estimated): January 8, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: KO_bariatria

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No