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A randomized, controlled, double-blind trial of patient-controlled sedation with propofol/remifentanil versus
Jeff E Mandel1, Jonathan W Tanner, Gary R Lichtenstein
1Department of Anesthesiology and Critical Care, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA. mandelj@uphs.upenn.edu
Background:
Patient-controlled sedation (PCS) with propofol has been advocated as a method for dealing with the narrow therapeutic window for moderate sedation, but previous studies have methodologic limitations. We hypothesized that, by using remifentanil in conjunction with propofol and using PCS in both arms of the study, we could demonstrate marked improvements in facility use compared with fentanyl plus midazolam.
Methods:
Fifty patients undergoing elective colonoscopy were randomized (with concealed allocation) to midazolam/fentanyl (group MF) or propofol/remifentanil (group PR) administered via PCS. Time intervals for sedation and recovery, perceptions by patient, nurse, and gastroenterologist, and need for anesthesiologist intervention were assessed.
Results:
Group PR patients were sedated and recovered significantly more rapidly than did group MF (P < 0.0001). In the group PR, recovery room time was actually shorter than procedure room time. Patient, nurse, and gastroenterologist perceptions were equivalent between the groups. Two patients in group PR required anesthesiologist intervention for arterial desaturation exceeding the primary safety end point.
Conclusions:
PCS with propofol/remifentanil yields superior facility throughput compared with midazolam/fentanyl when used in an appropriate care setting.
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