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The effect of personalized perioperative blood pressure management on intraoperative cerebral oxygen saturation, burst suppression ratio and postoperative neurological outcomes in patients having major surgery: an observational substudy of the IMPROVE-pilot trial

Conditions
euromonitoring and postoperative neurological outcome in patients participating in the IMPROVE pilot trial which investigates intraoperative personalized blood pressure managment
I95
Hypotension
Registration Number
DRKS00025762
Lead Sponsor
Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
55
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

- 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

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary exploratory endpoint: Referred to the individual preoperative baseline value, the integral of NIRS value and time (area under the curve). <br>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 Outcome Measures
NameTimeMethod
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