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

NCT ID: NCT03161275

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-04-30

Brief Summary

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

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

nirs

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%.

No interventions assigned to this group

cognitive function

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Skladzien

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Składzień, Ph.D

Role: STUDY_CHAIR

University Hospital in Cracow

Locations

University Hopital

Krakow, Małpololskie, Poland

Countries

Poland

Other Identifiers

K/ZDS/002839

Identifier Type: -

Identifier Source: org_study_id