Table 5.
External validation with clinical trials 19.4.207 (P05930) [13] and 19.4.210 (P05959) [14], showing time to recovery of the train-of-four (TOF) ratio to 0.9 (TOF90) and 0.7 (TOF70), following sugammadex reversal*
| Clinical trial | 19.4.207 (P05930) | 19.4.210 (P05959) | ||||||
|---|---|---|---|---|---|---|---|---|
| Anaesthesia | Propofol | Propofol | Sevoflurane | |||||
| End-point | Dose statistics | 0.5 mg kg−1sugammadex (n = 8) | 1.0 mg kg−1sugammadex (n = 7) | 2.0 mg kg−1sugammadex (n = 8) | 3.0 mg kg−1sugammadex (n = 3) | 4.0 mg kg−1sugammadex (n = 8) | 2.0 mg kg−1sugammadex (n = 21) | 2.0 mg kg−1sugammadex (n = 20) |
| Time to TOF90 (min) | Simulated median | 4.6 | 2.5 | 1.5 | 1.0 | 0.8 | 1.5 | 1.5 |
| Simulated 90% CI | 1.5–15 | 0.8–7.6 | 0.5–5.5 | 0.3–4.3 | 0.3–3.5 | 0.5–5.5 | 0.5–8.0 | |
| Observed median | 3.7 | 2.2 | 1.7 | 1.5 | 1.1 | 1.7 | 1.7 | |
| Observed range | 2.1–4.9 | 1.5–3.4 | 0.9–2.8 | 1.0–3.2 | 0.7–1.6 | 0.9–3.4 | 1.1–4.5 | |
| Time to TOF70 (min) | Simulated median | 3.5 | 2.0 | 1.3 | 0.8 | 0.8 | 1.1 | 1.3 |
| Simulated 90% CI | 1.2–11 | 0.7 −6.0 | 0.5–4.3 | 0.3–3.5 | 0.3–2.8 | 0.5–4.3 | 0.5–6.0 | |
| Observed median | 2.4 | 1.4 | 1.3 | 1.0 | 1.0 | 1.2 | 1.3 | |
| Observed range | 1.3–2.9 | 1.1–2.2 | 0.9–1.9 | 0.7–2.4 | 0.7–1.3 | 0.8–2.4 | 0.7–1.9 | |
Sugammadex was administered at reappearance of T2 (moderate blockade reversal).