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Precedex

Clinical Pharmacology
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Clinical Pharmacology

A prospective secondary analysis assessed the dose of morphine sulfate administered to patients in the dexmedetomidine and placebo groups. On average, dexmedetomidine-treated patients received less morphine sulfate for pain than placebo-treated patients (0.47 versus 0.83 mg/h). In addition, 44% (79 of 178 patients) of dexmedetomidine patients received no morphine sulfate for pain versus 19% (33 of 175 patients) in the placebo group.

In a second study, 198 patients were randomized to receive placebo and 203 to receive dexmedetomidine by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of 1 (one) mcg/kg IV over 10 minutes. The study drug infusion was adjusted to maintain a Ramsay sedation score of ≥ 3. Patients were allowed to receive “rescue” propofol as needed to augment the study drug infusion. In addition, morphine sulfate was administered as needed for pain. The primary outcome measure for this study was the total amount of rescue medication (propofol) needed to maintain sedation as specified while intubated.

Patients randomized to placebo received significantly more propofol than patients randomized to dexmedetomidine (see Table 4).

A significantly greater percentage of patients in the dexmedetomidine group compared to the placebo group maintained a Ramsay sedation score of ≥ 3 without receiving any propofol rescue (see Table 4).

Table 4: Propofol use as rescue medication during intubation (ITT) Study Two

  Placebo
N=198
Dexmedetomidine
N=203
p-value
Mean total dose (mg) of propofol 513 mg 72 mg < 0.0001*
Standard deviation 782 mg 249 mg  
Categorized propofol use      
0 mg 47 (24%) 122 (60%) < 0.001**
0-50 mg 30 (15%) 43 (21%)  
> 50 mg 121 (61%) 38 (19%)  
*ANOVA model with treatment center.
**Chi-square

A prospective secondary analysis assessed the dose of morphine sulfate administered to patients in the dexmedetomidine and placebo groups. On average, dexmedetomidine-treated patients received less morphine sulfate for pain than placebo-treated patients (0.43 versus 0.89 mg/h). In addition, 41% (83 of 203 patients) of dexmedetomidine patients received no morphine sulfate for pain versus 15% (30 of 198 patients) in the placebo group.

Brand Name: Precedex
Generic Name: Dexmedetomidine hydrochloride

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