Bispectral (BIS) electroencephalogram (EEG) monitored sedation in intensive care unit (ICU) patients. A preliminary randomised controlled trial
| ISRCTN | ISRCTN76377555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76377555 |
| Protocol serial number | N0436121370 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Mallick
Scientific
Scientific
Anaesthetics
D Floor, Jubilee Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 243 2799 |
|---|---|
| Abhiram.Mallick@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Bispectral (BIS) electroencephalogram (EEG) monitored sedation in intensive care unit (ICU) patients. A preliminary randomised controlled trial |
| Study objectives | The objective of this study is to investigate whether BIS monitoring has any impact on the sedative requirements in post cardiac surgery ICU patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sedation in post cardiac surgery |
| Intervention | Randomised controlled trial. Random allocation to: 1. Standard management 2. Standard management + BIS monitoring |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Comparison of amount of propofol used between the two randomised groups. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Postoperative cardiac surgery patients who are expected to have an uneventful postoperative recovery. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Anaesthetics
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
30/04/2018: No publications found, study status unverified.
09/03/2016: No publications found, verifying study status with principal investigator.
