Surgery: Anaesthesia Surgery Anaesthesia
Conditions
Interventions
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 (1
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed