Neuromonitoring and postoperative neurological outcome in patients participating in the IMPROVE pilot trial which investigates intraoperative personalized blood pressure managment I95
Conditions
Interventions
Group 1: Patients in the IMPROVE pilot study randomized to receive the personalized blood pressure management: Observation of neuromonitoring, cognitive function and delirium
Group 2: Patients in the
Sponsors
Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 45 - American Society of Anesthesiologists physical status class (ASA) II-IV - scheduled for elective major surgery under general anesthesia - surgery expected to last = 120 minutes
Exclusion criteria
Exclusion criteria: - emergency surgery - patients having liver or kidney transplantation - pregnancy - status of post transplantation of kidney, liver, heart, or lung - sepsis (according to current Sepsis-3 definition) - impossibility of preoperative automated blood pressure monitoring - MAP differences between the right and the left arm of more than 20 mmHg surgery that requires controlled hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary exploratory endpoint: Referred to the individual preoperative baseline value, the integral of NIRS value and time (area under the curve). The NIRS regional tissue oxygen saturation (rSO2) will be assessed using Masimo Sedline Monitoring. Before induction of anesthesia, non-invasive NIRS electrodes will be placed on the patient’s forehead to monitor cerebral regional oxygen saturation. The treating anesthesiologist will be blinded to the NIRS-Monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary exploratory endpoint: Burst supression rate. BSR will be monitored by non-invasive electrodes placed on the patient’s forehead using Masimo Sedline’s processed EEG (pEEG) - monitoring. The treating anesthesiologist will be blinded to the pEEG monitoring. Tertiary exploratory endpoint: Postoperative delirium (POD). POD will be assessed on postoperative days 1, 2, and 3 using the 3D-Confusion Assessment Method (3D-CAM), and the Confusion Assessment Method for Intensive Care Unit (CAM-ICU). Study personal involved in neurocognitive testing as well as participating patients will be blinded to group allocation. Quaternary endpoint: Delayed neurocognitive recovery. Delayed neurocognitive recovery.will be assessed on postoperative days 3, 7, and 30 using the telephone-Montreal Cognitive Assessment (T-MoCA). Study personal involved in neurocognitive testing as well as participating patients will be blinded to group allocation. Additional exploratory endpoint: The association between NIRS values (area under the curve, as explained above) and incidence of myocardial and kidney injury within the first three postoperative days will be evaluated. Myocardial and kidney injury will be assessed as described in the main protocol. | — |
Countries
Germany
Contacts
Public ContactLinda Grüßer
Klinik für Anästhesiologie, Universitätsklinikum RWTH Aachen
Outcome results
None listed