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

Anaesthetics
D Floor, Jubilee Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone +44 (0)113 243 2799
Email Abhiram.Mallick@leedsth.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific titleBispectral (BIS) electroencephalogram (EEG) monitored sedation in intensive care unit (ICU) patients. A preliminary randomised controlled trial
Study objectivesThe 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) studiedSedation in post cardiac surgery
InterventionRandomised controlled trial. Random allocation to:
1. Standard management
2. Standard management + BIS monitoring
Intervention typeProcedure/Surgery
Primary outcome measureComparison of amount of propofol used between the two randomised groups.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2002
Completion date01/06/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPostoperative cardiac surgery patients who are expected to have an uneventful postoperative recovery.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/2002
Date of final enrolment01/06/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Anaesthetics
Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.