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

J

Jagiellonian University

Status

Completed

Conditions

Surgical Complications From General Anesthesia
Cerebral Ischemia
Anesthesia; Reaction

Study type

Observational

Funder types

Other

Identifiers

NCT03161275
K/ZDS/002839

Details and patient eligibility

About

Subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled

Enrollment

101 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

101 participants in 2 patient groups

nirs
Description:
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
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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