Obese Patients

Obese patients with a body mass index (BMI) >30kg/m² were compared to normal weight subjects in a European study in which they received 1.5 mg/kg of RAPLON^TM as part of a rapid sequence induction of anesthesia using either fentanyl/thiopental or alfentanil/propofol. Patients were dosed based on actual body weight. Acceptable (excellent or good) intubating conditions following 1.5 mg/kg of RAPLON^TM were similar in obese (86% under fentanyl/thiopental, 92% under alfentanil/propofol) and normal weight subjects (87% under fentanyl/thiopental, 91% under alfentanil/propofol) at 60 seconds. The percent of excellent scores under fentanyl/thiopental of alfentanil/propofol were 48% and 65%, respectively in obese patients, and 44% and 52%, respectively, in normal weight patients.

Repeat Dosing in Adults

In three controlled clinical trials, after an initial intubating dose a RAPLON^TM of 1.5 mg/kg. 3 additional doses of 0.5 to 0.55 mg/kg were administered at 25% recovery of T₁ or at the reappearance of T₃(n=76). The duration of action of maintenance doses of 0.5 to 0.55 mg/kg ranged from 3 to 35 minutes. A statistically significant increase in the duration of action of RAPLON^TM was noted with subsequent maintenance doses (See Table 6).

Table 6: Clinical Duration (25% Recovery of T1) of Maintenance Doses of Raplon (minutes) following an initial intubating dose of 1.5 mg/kg

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