A prospective, randomised, double-blind, placebo-controlled trial to assess the respiratory effects of oxycodone versus morphine in anaesthetised patients - randomised, double-blind, placebo-controlled,respiratory effects, oxycodone, morphine
- Conditions
- Patients scheduled to undergo surgery of more than 30 minutes duration under general anaesthesia will be recruited. We are not investigating a medical disease.
- Registration Number
- EUCTR2006-003302-25-GB
- Lead Sponsor
- Barts and The London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method