ISRCTN36437985已完成未知

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 个研究点目标入组 1,600 人开始时间: 2009年6月3日最近更新: 2023年3月6日

适应症

试验速览

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)

•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

•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

发起方

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