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 |
| Secondary identifying numbers | N0436121370 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | Comparison of amount of propofol used between the two randomised groups. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2002 |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Anaesthetics
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Not defined
Leeds Teaching Hospitals NHS Trust
No information available
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 |
Editorial Notes
30/04/2018: No publications found, study status unverified.
09/03/2016: No publications found, verifying study status with principal investigator.
