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Health Condition(s) or Problem
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Signs and Symptoms: Post operative pain
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Lay Summary
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Sorry, not currently available
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Who can enter the trial
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Patients with preserved myocardial function undergoing elective myocardial revascularisation having given written informed consent.
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Who cannot enter the trial
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Not provided at time of registration
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What will happen
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Each volunteer will be randomly allocated (using random number tables) to one of two groups:
1. Intrathecal morphine/Remifentanil group
2. Fentanyl/Alfentanil (control) group
After transfer to the ITU the volunteer will remain sedated until they are haemodynamically stable, have a body temperature above 35 degrees Celsius, and are not excessively bleeding. At this point the sedative agent will be stopped and the volunteer will be extubated after specific extubation criteria have been met.
Data will be collected for the pre-, intra-, and post-operative periods.
One of the investigators will remain with the volunteer from the time of ITU admission to the end of the study period. He/she will be responsible for all data collection and will oversee the analgesic management.
The volunteer may request to withdraw from the study at any time. The investigator will withdraw the volunteer from the study if:
1. A critical incident occurs
2. There are peri-operative complications e.g. myocardial dysfunction requiring inotropic support
3. There is excessive post-operative bleeding
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Primary aim
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To compare the efficacy of intrathecal morphine and intravenous remifentanil against a standard analgesic technique in patients undergoing elective myocardial revascularisation.
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Secondary Aim
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Not provided at time of registration
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Birmingham
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