Obesity and Obesity-related Medical ConditionsNCT06759623
Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery
A study testing Different drug type for conduction of general anesthesia in people with Obesity and Obesity-related Medical Conditions, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Different drug type for conduction of general anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jan 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients qualified for bariatric surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Center
Gdansk
Karolina Obara, MD, 0048 58 349 32 80, kobara@uck.gda.pl
About this study
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
- Being tested
- Different drug type for conduction of general anesthesia
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia with desflurane | Experimental | Patients undergoing anesthesia for bariatric surgery with desflurane as a volatile agent. Receives: 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. Receives: Drug: Different drug type for conduction of general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (HR)
HR will be measured by ecg in beat per minute
Measured: Continuously during whole duration of anesthesia
Pulse oximetry (SpO2)
SpO2 will be measured by light spectrometry percutaneous sensor in %
Measured: 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.
Measured: Continuously during whole duration of anesthesia
Minimum alveolar concentration (MAC)
MAC will be measured based on exhaled anesthetic gas concentration in absolute numbers
Measured: Continuously during whole duration of anesthesia
Bispectral index (BIS)
BIS will be measured with Covidien BIS monitoring system in absolute numbers
Measured: Continuously during whole duration of anesthesia
Train of for (TOF)
TOF will be measured in absolute numbers
Measured: Every 2.5 minutes during whole duration of anesthesia
Non invasive blood pressure (NIBP)
NIBP will be measured with oscillometric method in mmHG
Measured: Every 5 minutes during whole duration of anesthesia
Forced vital capacity (FVC)
FVC will be measured with spirometry
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start8 Jan 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radosław Owczuk, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759623
- Sponsor's protocol ID
- KO_bariatria
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06759623
- Acronym / sponsor ID
- KO_bariatria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia with desflurane | Experimental | Drug: Different drug type for conduction of general anesthesiaPatients undergoing anesthesia for bariatric surgery with desflurane as a volatile agent. |
| General anesthesia with sevoflurane | Experimental | Drug: Different drug type for conduction of general anesthesiaPatients undergoing anesthesia for bariatric surgery with sevoflurane as a volatile agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese patients qualified for bariatric surgery.
Key exclusion criteria (7 listed)
- Patients who have absolute contraindications to spirometry testing, i.e:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different drug type for conduction of general anesthesiaPatients 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. | Drug | General anesthesia with desflurane, General anesthesia with sevoflurane |
Primary outcome
Heart rate (HR)
Time frame: Continuously during whole duration of anesthesia
HR will be measured by ecg in beat per minute
Pulse oximetry (SpO2)
Time frame: Continuously during whole duration of anesthesia
SpO2 will be measured by light spectrometry percutaneous sensor in %
End tidal CO2 (etCO2)
Time frame: 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.
Minimum alveolar concentration (MAC)
Time frame: Continuously during whole duration of anesthesia
MAC will be measured based on exhaled anesthetic gas concentration in absolute numbers
Bispectral index (BIS)
Time frame: Continuously during whole duration of anesthesia
BIS will be measured with Covidien BIS monitoring system in absolute numbers
Train of for (TOF)
Time frame: Every 2.5 minutes during whole duration of anesthesia
TOF will be measured in absolute numbers
Non invasive blood pressure (NIBP)
Time frame: Every 5 minutes during whole duration of anesthesia
NIBP will be measured with oscillometric method in mmHG
Forced vital capacity (FVC)
Time frame: 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)
Time frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
FEV1 will be measured with spirometry
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
MEF25 will be measured with spirometry
Mid-expiratory flow; the rates at 25% FVC (MEF50)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Fres will be measured with impulsed oscillometry
Area of reactance (Ax)
Time frame: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia
Ax will be measured with impulsed oscillometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different drug type for conduction of general anesthesia in people with Obesity and Obesity-related Medical Conditions, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karolina Obara, MD (0048 58 349 32 80, kobara@uck.gda.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (HR) (time frame: Continuously during whole duration of anesthesia). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.