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

NCT03161275 | Completed

• 1 other identifier: K/ZDS/002839
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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

Keywords

cerebral saturation; epidural anaesthesia; Near Infrared Spectroscopy (NIRS); Regional cerebral oxygen saturation

Outcome Measures

Primary Outcomes (1)

• cerebral saturation

  decreases in cerebral oxygen saturation (rSO2) during the surgery

  every 5 minutes throughout the surgery

Secondary Outcomes (1)

• the Mini Mental State Examination test

  Baseline, 4 day after surgery

Study Arms (2)

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%.

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One hundred and one (101) subsequent and non-randomised patients, age between 35 and 84 years (mean 64±10) hospitalised at the 1st Department of General, Oncologic and Gastroenterologic Surgery of the UJ CM in Krakow, qualified for abdominal surgeries were enrolled.

You may qualify if:

• scheduled for major abdominal surgery for at least 2 h
• under general anesthesia
• American Society of Anesthesiologists（ASA）physical status : II \~ III
• Age \> 18

You may not qualify if:

• refuse of patients
• patient with results of test: "The Mini Mental State Examination"" less then 24 before operation
• neurosurgery history of patients

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

University Hopital

Krakow, Małpololskie, 31-501, Poland

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tomasz Składzień, Ph.D

  University Hospital in Cracow

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 19, 2017
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)