A prospective, randomised, double-blind, placebo-controlled trial to assess the respiratory effects of oxycodone versus morphine in anaesthetised patients
| ISRCTN | ISRCTN30198912 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30198912 |
| Secondary identifying numbers | N0205190802 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 18/10/2011
- 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 Vivek Mehta
Scientific
Scientific
Anaesthetics Laboratory
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
| Phone | +44 0207601 7524 |
|---|---|
| vivek.mehta@bartsandthelondon.nhs.uk |
Study information
| Study design | Prospective randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To investigate to what extent modest and pre-defined degrees of respiratory depression may be produced by oxycodone and compare this to patients who receive intravenous morphine or placebo under identical conditions using a previously validated model. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | A prospective randomised double-blind placebo-controlled trial. Oxycodone 0.05mg/kg IV (12 patients), oxycodone 0.1mg/kg IV (12 patients), Oxycodone 0.2mg/kg IV (12 patients), morphine 0.1mg/kg IV (12 patients), or placebo - normal saline (6 patients) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | oxycodone versus morphine |
| Primary outcome measure | The extent to which oxycodone produces respiratory depression and compare this to morphine and placebo. The primary endpoint is time to respiratory depression, defined as respiratory rate decreased by ≥33% and or end-tidal CO² increased by ≥1.5kPa. |
| Secondary outcome measures | To evaluate the extent of reversibility of any such respiratory depression by the administration of naloxone. The principle secondary endpoint is the amount of naloxone required to reverse respiratory depression effects. |
| Overall study start date | 13/12/2006 |
| Completion date | 12/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Patients aged 18-55 years 2. Patients who are ASA 1-2 3. Patients must be inpatients 4. Patients who are due to undergo surgery of greater than 30 minutes duration under GA 5. Patient has given written informed consent 6. Patient weighs between 45 and 100kg, and/or BMI ≥30 |
| Key exclusion criteria | 1. Patients who are allergic to oxycodone, naloxone or morphine 2. Patients with a history of substance abuse 3. Patients with a history of anaesthetic complications 4. Patients who have been on long-term opioid therapy, or have taken strong opioids within the last two weeks 5. Patients who are considered unsuitable by the responsible anaesthetist - for whom the required lengthening of the anaesthesia time is deemed to constitute an unacceptable increased risk 6. Patients who are involved in existing research 7. Patients who have any condition predisposing to respiratory depression |
| Date of first enrolment | 13/12/2006 |
| Date of final enrolment | 12/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetics Laboratory
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Barts and The London NHS Trust
No information available
NHS R&D Support Funding
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No |
