Condition category
Surgery
Date applied
02/03/2009
Date assigned
03/06/2009
Last edited
02/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudia Spies

ORCID ID

Contact details

Charitéplatz 1
Berlin
10117
Germany
+49 (0)30 450 65 10 01
claudia.spies@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

Ethics Committee of Charité - Universitätsmedizin Berlin gave approval on the 22nd January 2009 (ref: EA1/242/08)

Study design

Prospective randomised controlled two-armed single centre pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2009

Overall trial end date

28/02/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

1600

Participant exclusion criteria

1. Aged less than 60 years
2. No written consent from patient
3. Inability to communicate freely in the German language
4. Lacking willingness to save and hand out pseudomised 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

01/03/2009

Recruitment end date

28/02/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Charitéplatz 1
Berlin
10117
Germany

Sponsor information

Organisation

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

Sponsor details

Chariteplatz 1
Berlin
10117
Germany
c.krukenkamp@charite.de

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23539235
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24979586

Publication citations

  1. Results

    Radtke FM, Franck M, Lendner J, Krüger S, Wernecke KD, Spies CD, Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction., Br J Anaesth, 2013, 110 Suppl 1, i98-105, doi: 10.1093/bja/aet055.

  2. Results

    Drews T, Franck M, Radtke FM, Weiss B, Krampe H, Brockhaus WR, Winterer G, Spies CD, Postoperative delirium is an independent risk factor for posttraumatic stress disorder in the elderly patient: A prospective observational study., Eur J Anaesthesiol, 2014, doi: 10.1097/EJA.0000000000000107.

Additional files

Editorial Notes