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Clinical Trials/ISRCTN36437985
ISRCTN36437985
Completed
N/A

Intra-operative depth of anaesthesia and influence on the incidence of post-operative cognitive deficits: a prospective, randomised, controlled, two-armed single centre pilot trial

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)0 sites1,600 target enrollmentJune 3, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
General anaesthesia
Sponsor
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Enrollment
1600
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23539235 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24979586 results 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36313029/ Retrospective data analysis (added 01/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36819718/ Secondary analysis (added 24/02/2023)

Registry
who.int
Start Date
June 3, 2009
End Date
February 28, 2012
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Eligibility Criteria

Inclusion Criteria

  • 1\. Written informed consent of the patient
  • 2\. Aged greater than or equal to 60 years, either sex
  • 3\. Patients undergoing elective general anaesthesia in Charité \- Universitätsmedizin Berlin, Campus Virchow\-Klinikum with a planned duration of procedure greater than or equal to 1 hour

Exclusion Criteria

  • 1\. Aged less than 60 years
  • 2\. No written consent from the patient
  • 3\. Inability to communicate freely in the German language
  • 4\. Lacking the willingness to save and hand out pseudonymised data within the clinical study
  • 5\. Simultaneous participation of the patient in a pharmaceutical study or having been in a study which was terminated less than a month ago or is planned within a week
  • 6\. Accommodation in an institution due to an official or judicial order
  • 7\. Members of staff of the Charité
  • 8\. History of intra\-operative awareness or other reason for unblinded BIS monitoring
  • 9\. Mini\-Mental Status Examination (MMSE) below 24 or known dementia

Outcomes

Primary Outcomes

Not specified

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