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
Protocol serial number	N0205190802
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Barts and The London NHS Trust, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Vivek Mehta
Scientific

Anaesthetics Laboratory
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Phone	+44 0207601 7524
Email	vivek.mehta@bartsandthelondon.nhs.uk

Primary study design	Interventional
Study design	Prospective randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	oxycodone versus morphine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	12/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Not Specified
Target sample size at registration	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

Anaesthetics Laboratory

London
EC1A 7BE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No