Contact information
Type
Scientific
Primary contact
Dr A Mallick
ORCID ID
Contact details
Anaesthetics
D Floor
Jubilee Building
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 243 2799
Abhiram.Mallick@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436121370
Study information
Scientific title
Bispectral (BIS) electroencephalogram (EEG) monitored sedation in intensive care unit (ICU) patients. A preliminary randomised controlled trial
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Sedation in post cardiac surgery
Intervention
Randomised controlled trial. Random allocation to:
1. Standard management
2. Standard management + BIS monitoring
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Comparison of amount of propofol used between the two randomised groups.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Postoperative cardiac surgery patients who are expected to have an uneventful postoperative recovery.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
01/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
Leeds Teaching Hospitals NHS Trust
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