A prospective randomised, double-blind, placebo controlled trial to assess the respiratory effects of buprenorphine versus morphine in anaethetised patients
| ISRCTN | ISRCTN41174967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41174967 |
| Protocol serial number | N0205120616 |
| Sponsor | Department of Health (UK) |
| Funder | Barts and The London NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Langford
Scientific
Scientific
Department of Anaesthetics
Royal London Hospital
Whitechapel Rd
London
E1 1BB
United Kingdom
| Phone | +44 (0)20 7377 7793 |
|---|---|
| r.m.langford@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This study is designed to investigate the effects of buprenorphine and morphine on respiratory parameters and in the event of changes occurring, the use of reversibility by naloxone (an opioid antagonist). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | Buprenorphine and morphine vs placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | buprenorphine and morphine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 90 |
| Key inclusion criteria | Patients that will have an operation lasting more than 30 min that require general anaesthetic, from Barts Hospital main theatres. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 07/02/2003 |
| Date of final enrolment | 31/07/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthetics
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | The study was presented to and accepted by the Anaesthetic Research Society, UK in December - Meeting in Leeds. The published abstract is cited as: Mehta V, Phillips JP, Wantman AC, Ratcliffe SH, van Raders PA, Langford RM. Investigation of buprenorphine induced respiratory depression in anaesthetised patients and its reversibility. British J Anaesthesia. 2005; 94: 399-400. See | 02/03/2008 | No | No |
