NCT06759623

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 8, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

December 28, 2024

Last Update Submit

December 28, 2024

Conditions

Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (17)

  • 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

Study Arms (2)

General anesthesia with desflurane

EXPERIMENTAL

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

Drug: Different drug type for conduction of general anesthesia

General anesthesia with sevoflurane

EXPERIMENTAL

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

Drug: Different drug type for conduction of general anesthesia

Interventions

Different drug type for conduction of general anesthesiaDRUG

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 desfluraneGeneral anesthesia with sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese patients qualified for bariatric surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center

Gdansk, Poland

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Karolina Obara, MD

CONTACT

0048 58 349 32 80kobara@uck.gda.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr hab.

Study Record Dates

First Submitted

December 28, 2024

First Posted

January 6, 2025

Study Start

January 8, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)