Contact information
Type
Scientific
Primary contact
Dr Vivek Mehta
ORCID ID
Contact details
Anaesthetics Laboratory
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
+44 0207601 7524
vivek.mehta@bartsandthelondon.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205190802
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
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 trial start date
13/12/2006
Overall trial end date
12/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant 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
Recruitment start date
13/12/2006
Recruitment end date
12/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics Laboratory
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20712805
Publication citations
-
Results
Chang SH, Maney KM, Phillips JP, Langford RM, Mehta V, A comparison of the respiratory effects of oxycodone versus morphine: a randomised, double-blind, placebo-controlled investigation., Anaesthesia, 2010, 65, 10, 1007-1012, doi: 10.1111/j.1365-2044.2010.06498.x.