The use of biphasic energy for cardioversion of atrial fibrillation under midazolam sedation. A comparison of results using monophasic and biphasic energies with short acting general anaesthesia (GA) and midazolam sedation
| ISRCTN | ISRCTN48624113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48624113 |
| Secondary identifying numbers | N0211114381 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 25/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 R Mitra
Scientific
Scientific
Royal Surrey County Hospital NHS Trust
Egerton Road
Guildford, Surrey
GU2 7XX
United Kingdom
| Phone | +44 (0)1483 571122 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To compare side effects of using higher traditional cardioverters with biphasic cardioversion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Midazolam |
| Primary outcome measure | 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 study start date | 01/12/2001 |
| Completion date | 28/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Adults with atrial fibrillation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 28/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Surrey County Hospital NHS Trust
Guildford, Surrey
GU2 7XX
United Kingdom
GU2 7XX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Royal Surrey County Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
