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

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

Study Overview

• Status: Completed
• Conditions: Surgical Complications From General Anesthesia; Anesthesia; Reaction; Cerebral Ischemia

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Poland
  • Małpololskie
    • Cracow, Małpololskie, Poland, 31-501
      • University Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Tomasz Składzień, Ph.D, University Hospital in Cracow

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (ACTUAL): May 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Near Infrared Spectroscopy (NIRS); epidural anaesthesia; Regional cerebral oxygen saturation; cerebral saturation
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID Numbers: K/ZDS/002839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The day before the surgery will be performed basic blood tests (morphology, gas analysis) and test "Short Scale Mental State Examination."; During the operation, in addition to standard monitoring the electrical activity of the heart, blood pressure and peripheral oxygen saturation levels, will be assessed non-invasively cerebral oximetry.; When during general anesthesia bradycardia occurs, then half of the patients in this group will be set up into the esophagus electrode, which will provide the ability to route atrial pacing hemodynamically optimal heart rate (80 / min). However, in the second half of the patients at the time of the occurrence of bradycardia is given intravenously at a dose of atropine 0.5 mg.; In about two hours after the surgery will be taken blood tests (morphology + gas analysis) to determine the potential impact of intraoperative bleeding changes oximetry.; On postoperative day 5 will be repeated test "Short Scale Mental State Examination"