J. Wahr et al., Effect of propofol with and without EDTA on haemodynamics and calcium and magnesium homeostasis during and after cardiac surgery, INTEN CAR M, 26, 2000, pp. S443-S451
Objective: To determine the effect of the addition of disodium edetate (EDT
A) to propofol on haemodynamics, ionised calcium and magnesium serum concen
trations, and adverse events during cardiac surgery.
Design: Double-blind, randomised, multicenter trial.
Setting: Operating room and intensive care unit of 5 academic health centre
s.
Patients: A total of 102 evaluable patients, aged 34 to 85 years, undergoin
g first-time, elective coronary artery bypass graft surgery.
Interventions: Comparison of propofol with EDTA and propofol without EDTA,
each in conjunction with the opioid sufentanil, for intraoperative anaesthe
sia and postoperative sedation.
Measurements and Results: There were no significant differences at any time
between the two formulations in any clinical chemistry measurements, inclu
ding ionised calcium, ionised magnesium, total calcium, parathyroid hormone
, blood urea nitrogen, creatinine, sodium, potassium, and phosphate. During
bypass, the mean concentration of ionised calcium decreased to below the n
ormal range, but the decrease was similar in both groups (propofol with EDT
A, 0.98 +/- 0.07 mmol/L [N = 51]; propofol, 0.99 +/- 0.10 mmol/ L, [N = 51]
; p = NS). Calcium concentration returned to normal after rewarming. Mean i
onised magnesium concentrations remained within in normal limits in both gr
oups. Similarly, there were no clinically meaningful differences between tr
eatments with respect to haemodynamic variables, efficacy variables, or inc
idence of adverse events.
Conclusions: The inclusion of EDTA in the current formulation of propofol a
ppears to have no significant effects on calcium and magnesium profiles, re
nal function, haemodynamic variables, or other indicators of safety and eff
icacy during intraoperative anaesthesia and postoperative sedation in patie
nts undergoing cardiac surgery.