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NCT03161275 Clinical Trial

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

Cerebral Ischemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03161275
Other study ID # K/ZDS/002839
Secondary ID
Status Completed
Phase N/A
First received May 16, 2016
Last updated May 17, 2017
Start date July 2012
Est. completion date April 2013

Study information
Verified date May 2017
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Poland University Hopital Cracow Malpololskie

Sponsors (1)
Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary cerebral saturation decreases in cerebral oxygen saturation (rSO2) during the surgery every 5 minutes throughout the surgery
Secondary the Mini Mental State Examination test to assessing the changes in the patients' cognitive function Baseline, 4 day after surgery
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