Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20712805

Publication citations

  1. 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.

Additional files

Editorial Notes