| |
|
|
|
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 |
|
