Patients scheduled to undergo surgery of more than 30 minutes duration under general anaesthesia will be recruited. We are not investigating a medical disease.
Conditions
Interventions
Trade Name: Oxycodone
Product Name: Oxycodone
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Solution for injection
Sponsors
Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18-55 years. Patients who are American Society of Anesthesiologists (ASA) Scores of I or II.(Generally fit and well, with no uncontrolled medical problems) They must be inpatients in hospital. Patients who are due to undergo surgery of greater than 30 minutes duration under general anaesthesia. Patients who weigh between 45kg and 100kg and/or a Body Mass Index of less than 30. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients undergoing emergency surgery. Patients who are allergic to oxycodone, naloxone or morphine. Patients with a history of substance abuse. Patients who have been on long-term opioid therapy, or have taken strong opioids within the last two weeks. Patients who are considered unsuitable by the responsible anaesthetist for whom lengthening of the anaesthetic time is deemed to constitute an unaccetable, increased risk. Patients who have any conidtion predisposing them to respiratory depression. Patients who are involved in existing research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate to what extent modest and pre-defined degrees of respiratory depression is produced by oxycodone and compare this to patients who receive intravenous morphine and placebo under identical conditions using a previously validated model.;Secondary Objective: The secondary objective is to evaluate the extent of reversibility of any such respiratory depression by administering naloxone.;Primary end point(s): The primary end point is to investigate the extent to which the study drug produces respiratory depression. This will be measured via continuous spirometry attached to the patient for 30 minutes after the dose is given. | — |
Countries
United Kingdom
Outcome results
None listed