Surgery Depth of anaesthesia Cognitive outcome (SuDoCo): a pilot study

Not Applicable

Completed

• Conditions: Surgery; General anaesthesia; Intra-operative anaesthesia

• Registration Number: ISRCTN36437985
• Lead Sponsor: Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-03
• Study Completion: 2012-02-28
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative delirium incidence (DSM-IV) measuring daily for one week or until hospital discharge (less than 7 days).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Intra-operative bispectral index parameter, measured during surgery<br> 2. Post-operative incidence of delirium (alternative Delirium scores), measured every post-operative day for one week until hospital discharge (less than 7 days)<br> 3. Post-operative incidence of cognitive dysfunction, measured on post-operative day 7 or on day of hospital discharge and day 90<br> 4. Time that discharge criteria were met, measured at discharge from recovery room and discharge from hospital<br> 5. Length of recovery room stay and total hospital stay (LOS)<br> 6. Quality of life measure (EQ-5D), measured on screening day and post-operative day 90<br> 7. Organ dysfunction, measured at hospital discharge<br> 8. Pain, measured in recovery room<br>