Safety and efficacy of propofol with EDTA when used for sedation of surgical intensive care unit patients.
OBJECTIVE
To compare propofol with disodium edetate (EDTA) and propofol without EDTAwhen used for the sedation of critically ill surgical intensive care unit (ICU) patients.


METHODS
Prospective, randomised, multicentre trial.


METHODS
A total of 122 surgical ICU patients who required intubation and mechanical ventilation.


METHODS
Patients were randomised to receive either propofol or propofol plus EDTA (propofol EDTA) by continuous infusion for sedation.


RESULTS
The addition of EDTA to propofol had no effect on calcium or magnesium homeostasis, renal function, haemodynamic function, or efficacy when used for the sedation of surgical patients in the ICU. The most common adverse events were hypotension, atrial fibrillation, and hypocalcaemia. In this trial, a greater number of serious adverse events and adverse events leading to withdrawal occurred in the propofol group relative to the propofol EDTA group. There was a significantly lower crude mortality rate at 7 and 28 days for the propofol EDTA group compared with the propofol group. There were no statistically significant differences between groups with respect to depth of sedation.


CONCLUSIONS
The propofol EDTA formulation had no effect on calcium or magnesium homeostasis, renal function, or sedation efficacy compared with propofol alone when used for sedation in critically ill surgical ICU patients. There was a significant decrease in mortality in the propofol EDTA group compared with the propofol group. Further investigations are needed to validate this survival benefit and elucidate a possible mechanism.
Herr
D L
DL
Washington Hospital Center, Washington DC 20010, USA.
Kelly
K
K
Hall
J B
JB
Ulatowski
J
J
Fulda
G J
GJ
Cason
B
B
Hickey
R
R
Nejman
A M
AM
Zaloga
G P
GP
Teres
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D018686:Anesthetics, Intravenous / Q000009:adverse effects / Q000494:pharmacology*; D002118:Calcium / Q000378:metabolism; D002614:Chelating Agents / Q000009:adverse effects / Q000494:pharmacology*; D003257:Consumer Product Safety; D004492:Edetic Acid / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006706:Homeostasis / Q000187:drug effects; D006801:Humans; D007362:Intensive Care Units; D008274:Magnesium / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000494:pharmacology*; D015742:Propofol / Q000009:adverse effects / Q000494:pharmacology*; D011446:Prospective Studies; D018709:Statistics, Nonparametric
D018686:Anesthetics, Intravenous; D002614:Chelating Agents; D011310:Preservatives, Pharmaceutical; D004492:Edetic Acid; D008274:Magnesium; D002118:Calcium; D015742:Propofol