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

NCT05293288 | Completed

• 1 other identifier: 2020-10155-BO-ff
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence and severity of intraoperative hypotension

  Outcome meassure will be assessed at the end of surgery

• Incidence and severity of intraoperative hypotension

  Outcome meassure will be assessed at the end of surgery

• Incidence and severity of intraoperative hypotension

  Outcome meassure will be assessed at the end of surgery

• Hospital length of stay

  Through study completion, an average of 1 year

• ICU length of stay

  Through study completion, an average of 1 year

Other Outcomes (1)

• Postoperative AKI

  30 days before the surgery until the first 7 postoperative days

Study Arms (2)

EEG-guided general anesthesia

EXPERIMENTAL

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.

Device: EEG-guided general anesthesia

Routine care

NO INTERVENTION

Routine care group (i.e., control group): Adjustment of depth of general anesthesia will be at the discretion of the treating anesthesiologist.

Interventions

EEG-guided general anesthesia DEVICE

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.

EEG-guided general anesthesia

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (1)

• Thomsen KK, Sessler DI, Krause L, Hoppe P, Opitz B, Kessler T, Chindris V, Bergholz A, Flick M, Kouz K, Zollner C, Schulte-Uentrop L, Saugel B. Processed electroencephalography-guided general anesthesia and norepinephrine requirements: A randomized trial in patients having vascular surgery. J Clin Anesth. 2024 Aug;95:111459. doi: 10.1016/j.jclinane.2024.111459. Epub 2024 Apr 9.

  PMID: 38599161 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 24, 2022
• Study Start: February 15, 2022
• Primary Completion: March 2, 2023
• Study Completion: August 16, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)