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

ISRCTN	ISRCTN36437985
DOI	https://doi.org/10.1186/ISRCTN36437985
Secondary identifying numbers	N/A

Submission date: 02/03/2009
Registration date: 03/06/2009
Last edited: 24/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Charitéplatz 1
Berlin
10117
Germany

Phone	+49 (0)30 450 65 10 01
Email	claudia.spies@charite.de

Study information

Study design	Prospective randomised controlled two-armed single-centre pilot trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	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
Study acronym	SuDoCo
Study hypothesis	Depth of anaesthesia monitored with a bispectral index (BIS) monitor is associated with the incidence of post-operative delirium in patients undergoing general anaesthesia.
Ethics approval(s)	Ethics Committee of Charité - Universitätsmedizin Berlin, 22/01/2009, ref: EA1/242/08 Added 04/05/2017: Secondary POCD-analyses of three trials ('Dexamethasone for Cardiac Surgery (DECS), The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart and SuDoCo) were approved in a separate ethics committee amendment vote of the SuDoCo trial on 26/01/2017 at Charité--Universitätsmedizin Berlin (ref: EA1/242/08). For this secondary analysis, no new data have been collected.
Condition	General anaesthesia
Intervention	In this study two different regimes during general anaesthesia are compared: 1. Unblinded BIS-monitoring (study group) 2. Blinded BIS-monitoring (control group) Duration of the treatment: during surgery Follow up: daily for one week until hospital discharge (less than 7 days), 3 months after procedure
Intervention type	Procedure/Surgery
Primary outcome measure	Post-operative delirium incidence (DSM-IV) measuring daily for one week or until hospital discharge (less than 7 days).
Secondary outcome measures	1. Intra-operative bispectral index parameter, measured during surgery 2. Post-operative incidence of delirium (alternative Delirium scores), measured every post-operative day for one week until hospital discharge (less than 7 days) 3. Post-operative incidence of cognitive dysfunction, measured on post-operative day 7 or on day of hospital discharge and day 90 4. Time that discharge criteria were met, measured at discharge from recovery room and discharge from hospital 5. Length of recovery room stay and total hospital stay (LOS) 6. Quality of life measure (EQ-5D), measured on screening day and post-operative day 90 7. Organ dysfunction, measured at hospital discharge 8. Pain, measured in recovery room
Overall study start date	01/03/2009
Overall study end date	28/02/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	1600
Participant 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
Participant 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
Recruitment start date	16/03/2009
Recruitment end date	30/08/2010

Locations

Countries of recruitment

Germany

Study participating centre

Charitéplatz 1

Berlin
10117
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Chariteplatz 1
Berlin
10117
Germany

Email	c.krukenkamp@charite.de
Website	http://www.charite.de/
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)

Alternative name(s): Medical School - Charité - University Medicine Berlin
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2013		Yes	No
Results article	results	01/03/2015		Yes	No
Other publications	Retrospective data analysis	14/10/2022	01/11/2022	Yes	No
Results article	Secondary analysis	01/02/2023	24/02/2023	Yes	No

Editorial Notes

24/02/2023: Publication reference added.
01/11/2022: Publication reference added.
05/04/2019: The recruitment dates were changed from 01/03/2009-28/02/2012 to 16/03/2009-30/08/2010.