Anesthesia, General Clinical Trial
Official title:
Metabolic and Physiological Changes During Minor Orthopaedic Surgery in Otherwise Healthy Patients
Verified date | June 2020 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The air we breathe contains 21% of oxygen. Oxygen is vital for the cells ability to produce
energy and without it we could not survive. Oxygen normally exists as a molecule consisting
of two atoms, O2. It has two unpaired electrons and thus is unstable and willing to accept
electrons to become stable. During the formation of ATP a transportation of electrons happens
over the inner membrane of the mitochondria's. Oxygen can accept these and is thereby reduced
to water. Normally about 4% is not fully reduced and instead produces superoxide. Superoxide
is transformed to hydrogen peroxide by superoxide dismutase (SOD) and then into oxygen and
water by catalase and glutathione peroxidase. It is also possible for hydrogen peroxide to be
converted to hydroxyl radicals by Fenton reactions. All these radicals are called reactive
oxygen species (ROS) and they are highly reactive and capable to induce damage to cellular
components as proteins, DNA and lipids. Under normal conditions SOD, catalase and glutathione
peroxidase work as anti-oxidative compounds to prevent oxidative stress and damage. However,
under hyperoxic conditions these defences can be overwhelmed, resulting in the formation of
excess ROS and thus oxidative damage.
During general anaesthesia the use of supplemental oxygen to avoid life-threatening
hypoxaemia has been common practice for many years and a fixed fraction of inspired oxygen
(FiO2) ranging from 0.3 to 1.0 is often used. This lead to supranormal levels of oxygen in
the lungs and most of the patients also have supranormal levels of partial pressure of
arterial oxygen in their blood.
This study will examine otherwise healthy ambulant patients undergoing minor orthopaedic
surgery during general anaesthesia to elucidate metabolic and physiological changes caused by
ventilation with FiO2 0.50 for at least 45 minutes using standard respiratory settings.
Exhaled breath condensate (EBC) and arterial blood will be collected prior to and after
surgery. The two EBCs and two blood samples will be stored at -80°C for analysis after all
patients have been included. The metabolic changes will be measured with NMR technique and
multivariate statistical analysis comparing baseline values with values obtained after oxygen
exposure.
Collapse of the small airways induced by anaesthesia and FiO2 will be evaluated by measuring
resistance and reactance with airway oscillometry after surgery compared to a baseline
measurement before surgery.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 22, 2017 |
Est. primary completion date | November 22, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Over the age of 18 years - Otherwise healthy (No major illness and not taking any medicine on a regular basis) - Non-smoker (Have never smoked or stopped smoking two years or more before the trial date) - Have given informed consent Exclusion Criteria: - Any respiratory infection in the past three months leading to consulting a doctor (Any infection in the lungs or the airways in the three months leading up to the trial that resulted in the participant consulting a doctor or taking any medication for the infection) - Any alcohol intake the last 24 hours (Drinking any alcohol in the last 24 hours up to the start of the trial) - Pregnancy (Confirmed by positive urine human gonadotropin (hCG) or plasma-hCG) |
Country | Name | City | State |
---|---|---|---|
Denmark | Departmen of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolites in exhaled breath condensate and in arterial blood | Metabolites measured by Nuclear Magnetic Resonance spectroscopy (NMR), explanatory study thus every changes in metabolites will be visualized | minor surgery (approximately 45-120 minutes) | |
Secondary | Minor airway resistance | Measured by oscillometry | minor surgery (approximately 45-120 minutes) | |
Secondary | Airway reactance | Measured by oscillometry | minor surgery (approximately 45-120 minutes) | |
Secondary | Mean arterial bloodpressure | Measured invasively | minor surgery (approximately 45-120 minutes) | |
Secondary | heart rate | changes in the heart rate meassured 30 minutes after the awakening from general anaesthesia compaired to baseline (30 minutes before surgery) | minor surgery (approximately 45-120 minutes) | |
Secondary | oxygen saturation | changes in the oxygen saturation meassured 30 minutes after the awakening from general anaesthesia compaired to baseline (30 minutes before surgery) | minor surgery (approximately 45-120 minutes) | |
Secondary | Partial pressure of arterial oxygen | Measured with blodgas analyzer (Radiometer, Denmark) | minor surgery (approximately 45-120 minutes) |
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