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)
Investigators
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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