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

NCT ID: NCT06759623

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2026-04-01

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

Conditions

Obesity and Obesity-related Medical Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

General anesthesia with desflurane

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

Group Type: EXPERIMENTAL

Different drug type for conduction of general anesthesia

Intervention Type: 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.

General anesthesia with sevoflurane

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

Group Type: EXPERIMENTAL

Different drug type for conduction of general anesthesia

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Radosław Owczuk

Prof. dr hab.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Clinical Center

Gdansk, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Karolina Obara, MD

Role: CONTACT

kobara@uck.gda.pl

0048 58 349 32 80

Facility Contacts

Karolina Obara, MD

Role: primary

kobara@uck.gda.pl

0048 58 349 32 80

Other Identifiers

KO_bariatria

Identifier Type: -

Identifier Source: org_study_id