Anesthesia, Sleep
Conditions
Brief summary
The investigators want to explore how presenting acoustic stimuli influences brain oscillatory signatures and heart rhythm- dynamics across different vigilance and sedation states. The investigators will administer acoustic stimuli during sedation and anaesthesia while brain activity and heart activity are being recorded by electroencephalogram and electrocardiogram. On the day following anaesthesia an optional nap/sleep period's EEG and ECG will be recorded. During this short sleep, patients will again be exposed to acoustic stimuli. The recorded EEG and ECG will be compared intra-and inter-individually to recordings from sedation and anaesthesia.
Interventions
OTHERAcoustic stimuli
During different states of sedation/anaesthesia and sleep, acoustic stimuli will be presented and compared to a within-subject baseline.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
This study is designed as non-randomized clinical study where acoustic stimuli of different characteristics are played and compared to within-subject baselines across various sedation and/or sleep states.
Intervention model description
The investigators forecast a maximal enrollment of 80 participants. However, an interim-analysis will be conducted after 10-14 participants to check estimated effect-size of intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent as documented by signature * Good general health status * Planned ophthalmic/plastic surgery at Inselspital Berne
Exclusion criteria
* Contraindications on ethical grounds * Neurological/neurodegenerative disorder * Hearing problems (only if patients are not able to perceive the acoustic stimuli) * Pacemaker * Deep brain stimulator * Pregnancy * Known or suspected drug or alcohol abuse * Critical surgery procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain oscillatory power derived by EEG | Continuously across anaesthesia/sedation/sleep up to 8 hours | Brain oscillatory response to acoustic stimuli derived by power spectral density in canonical frequency bands from 0.5 up to 40 Hz. |
| Brain oscillatory response derived by Hilbert Amplitude | Continuously across anaesthesia/sedation/sleep up to 8 hours | Brain oscillatory response to acoustic stimuli derived by Hilbert-transforming EEG data and extracting Hilbert amplitude in microVolts |
| Spindle characteristics - number of spindles | Continuously across anaesthesia/sedation/sleep up to 8 hours | Number of spindles |
| Spindle characteristics - amplitude of spindles | Continuously across anaesthesia/sedation/sleep up to 8 hours | Spindle amplitude in microVolts |
| Spindle characteristics - frequency of spindles | Continuously across anaesthesia/sedation/sleep up to 8 hours | Frequency of spindles in Hz |
| Spindle characteristics - duration of spindles | Continuously across anaesthesia/sedation/sleep up to 8 hours | Duration of spindles in ms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slow wave characteristics - slope | Continuously across anaesthesia/sedation/sleep up to 8 hours | Slope of slow waves in microVolts/s |
| Heart rate | Continuously across anaesthesia/sedation/sleep up to 8 hours | Heart rate derived from echocardiogram in bpm |
| Number of sleep arousals | Continuously across sleep up to 8 hours | — |
| Instantaneous heart rate | Continuously across anaesthesia/sedation/sleep up to 8 hours | Instantaneous heart rate derived from echocardiogram in bpm |
| Heart rate variability | Continuously across anaesthesia/sedation/sleep up to 8 hours | Heart rate variability derived from echocardiogram in ms |
| Slow wave characteristics - amplitude | Continuously across anaesthesia/sedation/sleep up to 8 hours | Slow wave amplitude in microVolt |
| Slow wave characteristics - number | Continuously across anaesthesia/sedation/sleep up to 8 hours | Number of slow waves |
| Slow wave characteristics - frequency | Continuously across anaesthesia/sedation/sleep up to 8 hours | Frequency of slow waves in Hz |
Countries
Switzerland
Contacts
Primary ContactFriedrich Lesch, MD, MSc.
Outcome results
None listed