Clinical trial NCT05293288: Effect of EEG-guided General Anesthesia on Cumulative Dose of Norepinephrine
Official title: EEG-guided General Anesthesia vs. Routine Care and Cumulative Dose of Norepinephrine in Patients Having Vascular Surgery: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 110
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: We will include consenting patients ≥45 years scheduled for elective vascular surgery under general anesthesia if:

* surgery is expected to last at least 60 min AND
* the estimated blood loss during surgery is less than 1000 mL AND
* intraarterial blood pressure monitoring (arterial catheter) is planned during surgery

We will not include patients with previous transplantation of kidney, liver, heart, or lung and those who are septic (according to current Sepsis-3 definition). And we will not include patients with American Society of Anesthesiologists' physical status V and VI, or pregnancy.

We will exclude patients after randomization if they were treated with vasopressors others than norepinephrine during surgery.

Written informed consent will be obtained from all patients prior to study inclusion.

Primary outcomes:
measure: Cumulative norepinephrine dose
timeFrame: Outcome meassure will be assessed at the end of surgery
Secondary outcomes:
measure: Incidence and severity of intraoperative hypotension
timeFrame: Outcome meassure will be assessed at the end of surgery
measure: Incidence and severity of intraoperative hypotension
timeFrame: Outcome meassure will be assessed at the end of surgery
measure: Incidence and severity of intraoperative hypotension
timeFrame: Outcome meassure will be assessed at the end of surgery
measure: Hospital length of stay
timeFrame: Through study completion, an average of 1 year
measure: ICU length of stay
timeFrame: Through study completion, an average of 1 year
measure: Hospital mortality
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Postoperative AKI
timeFrame: 30 days before the surgery until the first 7 postoperative days
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: