Table 6.
Number of animals per group with side effects* or adverse events** recorded during the study
|
Treatment group |
Total | ||||||
|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| Number of patients in group |
23 |
25 |
25 |
22 |
22 |
21 |
138 |
| Number of patients receiving atropine |
0 |
0 |
1 |
10 |
21 |
6 |
38 |
| Side effect (Adverse event) |
No. patients experiencing side effect or adverse event ( ) |
||||||
| Hypotension |
|
1 (1) |
1 (1) |
3 (2) |
9 (1) |
2 (2) |
16 (7) |
| Apnea |
1 (2) |
6 (6) |
2 (1) |
3 (2) |
3 (1) |
|
15 (12) |
| Bradycardia |
1 (1) |
1 (1) |
2 (1) |
1 |
1 |
6 (6) |
11 (9) |
| Excitation |
1 |
2 |
1 |
6 |
2 |
1 |
13 |
| Tachypnea |
1 |
2 |
|
3 |
1 |
|
7 |
| Arrhythmias |
|
|
|
1 (1) |
1 |
|
2 (1) |
| Paddling |
2 |
1 |
|
|
|
1 |
4 |
| Fasciculation |
|
2 |
|
1 |
|
1 |
4 |
| Tenseness |
1 |
1 |
1 |
|
|
|
3 |
| Hypertension |
|
|
|
|
|
3 |
3 |
| Cyanosis |
1 |
|
|
|
1 (1) |
|
2 (1) |
| Tachycardia |
|
|
|
1 |
1 |
|
2 |
| Salivation |
1 |
|
|
|
|
1 |
2 |
| Emesis |
|
|
|
|
1 (1) |
|
1 (1) |
| Death | (1) | 1 (1) | |||||
*Quantitative side effects defined as physiological measurements outside the normal range.
**Quantitative adverse reactions defined as: heart rate less than 50 bpm, apnea >120 seconds, mean arterial blood pressure < 50 mmHg, any potentially lethal ECG rhythm, mean O2 saturation <80% (any duration) or 90% for > 3 min.