Effect of EEG-guided General Anesthesia on Cumulative Dose of Norepinephrine

Hypotension Clinical Trial

Official title:

EEG-guided General Anesthesia vs. Routine Care and Cumulative Dose of Norepinephrine in Patients Having Vascular Surgery: a Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293288
• Other study ID #: 2020-10155-BO-ff
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: November 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 16, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• EEG-guided general anesthesia
pEEG monitoring will start with the beginning of induction of general anesthesia and will end with the end of surgery (surgical suture). In the EEG-guided group, depth of anesthesia will be adjusted to target PSI values between 25 and 50 and spectral edge frequency between 10 and 15. In case of contradictory values, the raw EEG waveforms, ARTF, EMG, as well as the overall clinical situation will be evaluated for decision making.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative AKI	Postoperative AKI defined as an increase in serum creatinine concentration of =0.3 mg/dL within any 48 h period within 7 postoperative days or of =50% from baseline within the first 7 postoperative days (based on: Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. The preoperative baseline serum creatinine concentration will be defined as the most recent recorded measurement within 30 days before the surgery. We will consider AKI as a binary outcome (no AKI vs. AKI of any stage). We will consider serum creatinine values when measured per routine care.	30 days before the surgery until the first 7 postoperative days
Primary	Cumulative norepinephrine dose	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	Outcome meassure will be assessed at the end of surgery
Secondary	Incidence and severity of intraoperative hypotension	Cumulative minutes below MAP of 65 mmHg	Outcome meassure will be assessed at the end of surgery
Secondary	Incidence and severity of intraoperative hypotension	Area under a mean arterial pressure of 65 mmHg	Outcome meassure will be assessed at the end of surgery
Secondary	Incidence and severity of intraoperative hypotension	Time-weighted average MAP under 65 mmHg	Outcome meassure will be assessed at the end of surgery
Secondary	Hospital length of stay	Hospital length of stay	Through study completion, an average of 1 year
Secondary	ICU length of stay	ICU length of stay	Through study completion, an average of 1 year
Secondary	Hospital mortality	Hospital mortality	Through study completion, an average of 1 year