Effect of EEG-guided General Anesthesia on Cumulative Dose of Norepinephrine
- Conditions
- Hypotension
- Interventions
- Device: EEG-guided general anesthesia
- Registration Number
- NCT05293288
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Intraoperative hypotension is common in patients having non-cardiac surgery under general anesthesia and is associated with major postoperative complications including myocardial injury, AKI, and death.
Intraoperative hypotension is also common in patients having vascular surgery. To treat intraoperative hypotension, vasopressors - such as norepinephrine - and fluids are used. However, high-dose vasopressor and excessive fluid therapy are also associated with postoperative complications.
The depth of general anesthesia may be a modifiable cause of intraoperative hypotension. Deep levels of general anesthesia may cause cardiovascular depression with intraoperative hypotension and higher vasopressor requirements. Optimal depth of general anesthesia is defined as a state in which the patient is at low risk of recall of intraoperative events while maintaining blood pressure stability with minimal intervention.
Depth of anesthesia can be confirmed using clinical signs, the concentration of inhaled or intravenous anesthetics, or neuromonitoring such as processed electroencephalography (pEEG). pEEG presents an opportunity to monitor changes in human brain electrical activity and to help estimating the patients' level of (un)consciousness and the optimal depth of anesthesia. EEG-guided general anesthesia may thus decrease norepinephrine doses needed to treat intraoperative hypotension in patients having surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EEG-guided general anesthesia EEG-guided general anesthesia EEG-guided general anesthesia group (i.e., intervention group): For pEEG monitoring we will use the SEDLine monitor (Masimo, Irvine, CA) which provides the patient state index (PSi; a processed EEG parameter with values from 1 to 100), density spectral array (DSA; a display that represents the frequencies and amplitudes of brain waves through time), spectral edge frequency (SEF), and the raw EEG signal.
- Primary Outcome Measures
Name Time Method Cumulative norepinephrine dose Outcome meassure will be assessed at the end of surgery Time-weighted cumulative norepinephrine dose normalized to the patient's actual body weight: cumulative norepinephrine dose \[µg\] / body weight \[kg\] / length of surgery \[min\]; unit: µg/kg/min
- Secondary Outcome Measures
Name Time Method Hospital mortality Through study completion, an average of 1 year Hospital mortality
ICU length of stay Through study completion, an average of 1 year ICU length of stay
Incidence and severity of intraoperative hypotension Outcome meassure will be assessed at the end of surgery Time-weighted average MAP under 65 mmHg
Hospital length of stay Through study completion, an average of 1 year Hospital length of stay
Trial Locations
- Locations (1)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany