Chest
Clinical Investigations in Critical CarePropofol vs Midazolam for ICU Sedation: A Canadian Multicenter Randomized Trial
Section snippets
Trial Design
This study was a multicenter, randomized, open-label trial conducted in four ICUs in academic medical centers across Canada. These centers were characterized as follows: center 1, a surgical and trauma ICU; center 2, a mixed population of medical-surgical patients and the regional trauma unit; center 3, a mixed medical-surgical unit that also admitted postoperative cardiac surgical cases; and center 4, a mixed medical-surgical unit that was a referral center for patients with difficult,
Results
The trial flow diagram28 is presented in Figure 1. Initial treatment assignment and stratification were equally distributed among centers (data not shown). The trial was terminated prematurely for fiscal reasons.
There were 11 deaths in the midazolam group (13.9%) and 15 deaths (19.5%) in the propofol group (p = 0.37). Hypotension and ventricular tachycardia leading to death developed in one patient receiving propofol, and propofol administration was thought to have possibly contributed to that
Discussion
In this multicenter randomized trial, the use of propofol compared to midazolam for sedation of patients in the ICU was associated with a reduced time to tracheal extubation in evaluable patients, but there was either no difference or a prolonged time to ICU discharge.
We can only speculate as to why ICU discharge was delayed. It could perhaps be explained by problems in the systematic handling of patients within these institutions. For example, any pharmacokinetic advantage to earlier tracheal
Conclusion
Propofol was a satisfactory agent for ICU sedation in this randomized multicenter trial. It permitted earlier tracheal extubation compared to midazolam but did not permit earlier ICU discharge.
Additional Study Investigators
David Stewart, MSc, Study Monitor, Ottawa Civic Hospital, Ottawa, Ontario, Canada; Hugh Devitt, MD, Safety Review Committee, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Craig Guenther, MD, Safety Review Committee, University of Alberta Hospitals, Edmonton, Alberta, Canada; Mauricio Calero, MD, Commercial Products Manager, Zeneca Pharma Inc., Mississauga, Ontario, Canada; and Hector Leon, BSc STAT, Data Entry and Statistical Analysis, St. Paul's Hospital, Vancouver, British
Ramsay Sedation Scale
- 1.
Anxious and agitated, or restless, or both22
- 2.
Cooperative, oriented, and tranquil
- 3.
Responding to commands only
- 4.
Brisk response to glabellar tap
- 5.
Sluggish response to glabellar tap
- 6.
No response to light glabellar tap
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Cited by (0)
Presented in part to the American College of Chest Physicians Annual Meeting, New Orleans, LA, October 26––30, 1997.
This research was supported by Zeneca Pharma Inc. Canada. Dr. Hall has received consultation fees from Zeneca Pharma Inc. and Hoffman-LaRoche Limited. He has no equity interest in either company. Drs. Sandham, Cardinal, Tweeddale, and Anis, and Mr. Moher and Mrs. Wang have no financial relationship with either company.
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A list of additional study investigators is located in Appendix 1