Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0211114381
Study information
Scientific title
Acronym
Study hypothesis
To compare side effects of using higher traditional cardioverters with biphasic cardioversion.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular: Atrial fibrillation (AF)
Intervention
Group 1 - Monophasic direct current cardioversion (DCCV) with midazolam sedation
Group 2 - Biphasic DCCV with midazolam sedation
Group 3 - Monophasic DCCV with short acting GA (propofol)
Group 4 - Biphasic DCCV with short acting GA (propofol)
Intervention type
Drug
Phase
Not Specified
Drug names
Midazolam
Primary outcome measures
1. Side effects of higher energy
2. Efficacy
3. Patient tolerance
4. Quantity of drugs
5. Length of stay in hospital (day case)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2001
Overall trial end date
28/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Adults with atrial fibrillation
Participant type
Patient
Age group
Adult
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
01/12/2001
Recruitment end date
28/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Surrey County Hospital NHS Trust
Guildford, Surrey
GU2 7XX
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
Government
Funder name
Royal Surrey County Hospital 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