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

Sponsor

Jagiellonian University (Other)

Overall Status

Completed

CT.gov ID

NCT03161275

Collaborator

(none)

101

Enrollment

Location

Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Complications From General Anesthesia Cerebral Ischemia Anesthesia; Reaction

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

101 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

cerebral saturation [every 5 minutes throughout the surgery]
decreases in cerebral oxygen saturation (rSO2) during the surgery

Secondary Outcome Measures

the Mini Mental State Examination test [Baseline, 4 day after surgery]
to assessing the changes in the patients' cognitive function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hopital	Cracow	Małpololskie	Poland	31-501

Sponsors and Collaborators

Jagiellonian University

Investigators

Study Chair: Tomasz Składzień, Ph.D, University Hospital in Cracow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomasz Skladzien, Ph.D., Jagiellonian University

ClinicalTrials.gov Identifier:

NCT03161275

Other Study ID Numbers:

K/ZDS/002839

First Posted:

May 19, 2017

Last Update Posted:

May 19, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Tomasz Skladzien, Ph.D., Jagiellonian University

cerebral saturation

epidural anaesthesia

Near Infrared Spectroscopy (NIRS)

Regional cerebral oxygen saturation

Additional relevant MeSH terms:

Brain Ischemia

Cerebral Infarction

Ischemia

Study Results

No Results Posted as of May 19, 2017