number of patients
number of patients 10 mg/kg 6.5 mg/kg Placebo Δ 95% CI P
N 5 2 5      
Demographics
Age (y); mean (SD) 73.1 (7.8) 71.5 (4.3) 72.2 (11.6) 1.6 (7.2) -14 to 17 0.81
Female 3 (60%) 0 (0%) 4 (80%)     0.43
Weight (kg); mean (SD) 77.2 (7.2) 89.8 (2.5) 91.2 (21.4) -12.6 (6.5) -27 to 1.4 0.07
ASA P3 4 (80%) 0 (0%) 2 (40%) 0.80   0.14
Sedation Outcomes
Sedation within 4 min 5 (100%) 1(50%) 2(40%) 0.50 -0.26 to 0.99 0.29
Sedation with One Dosea 5 (100%) 2(100%) 2(40%) 0.00 -0.52 to 0.84 >0.99
Sedation with Two Doses NA NA 1/3 (33%) NA NA NA
Additional Sedative 0(0%) 0(0%) 3(60%) 0.00 -0.84 to 0.52 >0.99
Modified Dose 4(80%) 1(50%) 4(80%) 0.30 -0.47 to 0.90 >0.99
Recovery Outcomes
Time to Sedation (min) mean (SD) 2.0(0.0) 5.0(4.2) 7.4(5.6) -3.0(1.9) -7.1 to 1.1 0.07
Recovery Time (min) mean (SD) 20.4 (10.7) 11.0 (4.2) 14.8(7.8) 9.4(9.8) -12 to 30 0.12
Recovered Prior to OR 3(60%) 2 (100%) 4(80%) -0.40 -0.85 to 0.52 >0.99
Adverse Events
Total Other 5(100%) 1(50%) 2(40%) 0.50 -0.26 to 0.99 0.29
Deep Sedation 5(100%) 0(0%) 1(20%) 1.00 0.07 to 1.00 0.048
Delayed Recovery 2(40%) 0(0%) 2(40%) 0.40 -0.52 to 0.85 >0.99
Paresthesia or Pruritus 3(60%) 1(50%) 0(0%) 0.10 -0.64 to 0.78 >0.99
Table 5: Statistical analysis of completed study patients’ primary outcomes. aprimary outcome measure.