TABLE 3.
SERSDA | Minute | Visit one |
Visit two |
Visit three |
Visit four |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 30 | 60 | 240 | 0 | 30 | 60 | 240 | 0 | 30 | 60 | 240 | 0 | 30 | 60 | 240 | ||
Fatigue | Mean | 2.9 | 1 | 0.7 | 0.8 | 1.4 | 1.6 | 1.2 | 1 | 1.6 | 1.3 | 1.2 | 0.8 | 1.5 | 1 | 1.2 | 0.7 |
SD | 0.88 | 1.15 | 0.95 | 0.92 | 0.84 | 1.17 | 1.23 | 0.82 | 0.7 | 1.1 | 1.1 | 1.03 | 1.27 | 1.25 | 1.03 | 0.67 | |
Dizziness | Mean | 0.6 | 0.1 | 0 | 0 | 0.1 | 0.8 | 0.3 | 0 | 0 | 0.3 | 0.1 | 0 | 0 | 0.5 | 0.2 | 0 |
SD | 0.97 | 0.32 | 0 | 0 | 0.32 | 1.14 | 0.95 | 0 | 0 | 0.67 | 0.32 | 0 | 0 | 0.71 | 0.63 | 0 | |
Nausea | Mean | 0.2 | 0.3 | 0.2 | 0.1 | 0.3 | 0.8 | 0.6 | 0 | 0.1 | 0.4 | 0.1 | 0.4 | 0.1 | 0.3 | 0.3 | 0.4 |
SD | 0.42 | 0.95 | 0.63 | 0.32 | 0.67 | 1.32 | 1.07 | 0 | 0.32 | 0.97 | 0.32 | 0.97 | 0.32 | 0.67 | 0.67 | 1.26 | |
Headache | Mean | 0.2 | 0 | 0 | 0 | 0 | 0.1 | 0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SD | 0.63 | 0 | 0 | 0 | 0 | 0.32 | 0.32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Feeling of unreality | Mean | 0.2 | 0.4 | 0 | 0 | 0 | 1.3 | 0.5 | 0.2 | 0 | 0.2 | 0 | 0 | 0 | 0.2 | 0.1 | 0 |
SD | 0.63 | 1.27 | 0 | 0 | 0 | 1.42 | 1.27 | 0.63 | 0 | 0.42 | 0 | 0 | 0 | 0.42 | 0.32 | 0 | |
Hearing change | Mean | 0 | 0 | 0 | 0 | 0 | 0.1 | 0 | 0.3a | 0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SD | 0 | 0 | 0 | 0 | 0 | 0.32 | 0 | 0.95 | 0.32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Vision change | Mean | 0.4 | 0.1 | 0 | 0 | 0.1 | 0.5 | 0.1 | 0 | 0.1 | 0.1 | 0 | 0 | 0 | 0.1 | 0.1 | 0 |
SD | 0.7 | 0.32 | 0 | 0 | 0.32 | 0.85 | 0.32 | 0 | 0.32 | 0.32 | 0 | 0 | 0 | 0.32 | 0.32 | 0 | |
Mood change | Mean | 0.5 | 0 | 0 | 0 | 0 | 0.6 | 0.4 | 0 | 0 | 0.1 | 0 | 0 | 0.5 | 0.4 | 0.1 | 0.3 |
SD | 0.85 | 0 | 0 | 0 | 0 | 1.26 | 1.26 | 0 | 0 | 0.32 | 0 | 0 | 1.08 | 0.7 | 0.32 | 0.67 | |
General discomfort | Mean | 1.6 | 0.9 | 0.6 | 0.5 | 1.3 | 1.1 | 0.8 | 0.8 | 1.2 | 0.8 | 0.8 | 0.8 | 1.1 | 0.8 | 0.8 | 1.2 |
SD | 1.51 | 1.37 | 1.35 | 1.08 | 1.38 | 1.45 | 1.32 | 1.32 | 1.32 | 1.32 | 1.32 | 1.32 | 1.45 | 1.14 | 1.32 | 1.62 | |
Hallucination | Mean | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Abbreviations: SD, standard deviation; SERSDA, Side Effects Rating Scale for Dissociative Anesthetics.
One subject reported hearing changes at 240 min mark rated as 3 on a scale of 0–4. However, he had chronic ringing in the ears, and this change was unlikely due to the study medication effect.