Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0019186908
Study information
Scientific title
BIS monitoring and depth anaesthesia for cardioversion
Acronym
Study hypothesis
To compare differences in the haemodynamic parameters during cardioversion with sevoflurane and propofol anaesthesia.
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
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Surgery: Anaesthesia
Intervention
BIS monitoring vs standard treatment
Intervention type
Drug
Phase
Not Applicable
Drug names
Sevoflurane, propofol
Primary outcome measures
Optimisation of depth of anaesthesia
Secondary outcome measures
To assess appropriateness of using BIS monitor when anaesthetising patients for cardioversion
Overall trial start date
08/11/2006
Overall trial end date
01/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing elective day case cardioversions for cardiac arrhythmias
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Any patient not willing to consent or not able to consent, with history of malignant hyperthermia or hypersensitivity to propofol
Recruitment start date
08/11/2006
Recruitment end date
01/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Conquest Hospital
St Leonards on Sea
TN37 7RD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Sussex Hospitals NHS Trust (UK)
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