Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

09/03/2016: No publications found, verifying study status with principal investigator.