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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36437985

Enrollment

1600

Registered

2009-06-03

Start date

2009-03-16

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anaesthesia Surgery Intra-operative anaesthesia

Interventions

In this study two different regimes during general anaesthesia are compared: 1. Unblinded BIS-monitoring (study group) 2. Blinded BIS-monitoring (control group)

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026