Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery

Study Overview
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Brief Summary
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Subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled

Official Title
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Measurement of the Cerebral Saturation for Assessment of Safety of Epidural Anaesthesia During Abdominal Surgery

Conditions
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Surgical Complications From General Anesthesia, Cerebral Ischemia, Anesthesia; Reaction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for major abdominal surgery for at least 2 h under general anesthesia American Society of Anesthesiologists（ASA）physical status : II   III Age > 18 Exclusion Criteria: refuse of patients patient with results of test: The Mini Mental State Examination less then 24 before operation neurosurgery history of patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nirs<br>The cerebral oxymetry saturation was monitored continuously, using a non-invasive method. The cerebral saturation was monitored intraoperatively with near infrared spectroscopy (INVOS 4100; Somanetics Inc, Troy, MI). Data acquired from the device were automatically and continuously recorded in 10-second intervals throughout the anaesthesia. A lead for the cerebral saturation monitoring was placed on degreased skin on the patient's forehead, on the right side, some 1 cm over the eyebrow. The baseline value was determined before induction of anaesthesia. The following criteria were accepted as significant reduction of the cerebral oxygenation (saturation) value: reduction of the cerebral oxymetry by over 25% in relation to the baseline; the absolute value of cerebral oxymetry below 50%. | |
| cognitive function<br>Upon the day preceding the actual surgery, and again at 5 days after the surgery, the Mini Mental State Examination test was completed, with a view to assessing the chang-es in the patients' cognitive function. The difference between score in Mini Mental State Examination higher than 2 points defined a diagnosis of cognitive dysfunction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral saturation | decreases in cerebral oxygen saturation (rSO2) during the surgery | every 5 minutes throughout the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Mini Mental State Examination test | to assessing the changes in the patients' cognitive function | Baseline, 4 day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral saturation, epidural anaesthesia, Near Infrared Spectroscopy (NIRS), Regional cerebral oxygen saturation