Patient characteristics and outcomes in three starting doses
| Dosing groups | Comparison between groups | |||||
| 1.0 mg/kg (n=30) | 1.5 mg/kg (n=23) | 2.0 mg/kg (n=26) | 1.0 vs 1.5 | 1.0 vs 2.0 | 1.5 vs 2.0 | |
| Patientcharacteristics | ||||||
| Gestational age (week), median (IQR) | 27.5 (25.86–30.93) | 26.86 (25.57–30.14) | 29.07 (26.43–31.71) | P=0.37 | P=0.66 | P=0.20 |
| Birth weight (g), median (IQR) | 1075 (784–1410) | 908 (780–1600) | 1215 (895–1568) | P=0.46 | P=0.51 | P=0.19 |
| Postnatal age (hour), median (IQR) | 156 (12–397) | 37.35 (21–387) | 19.58 (8–43) | P=0.68 | P=0.01 | P=0.04 |
| Male gender, n (%) | 22 (73) | 12 (52) | 18 (69) | P=0.16 | P=0.77 | P=0.25 |
| Propofol dosing | ||||||
| Extra propofol administered, n (%) | 25 (83) | 20 (87) | 11 (42) | P=1.0 | P=0.002 | P=0.002 |
| Cumulative propofol dose (mg/kg), median (IQR) | 3.0 (1.9–4.0) | 3.4 (2.5–4.5) | 2.0 (2.0–3.0) | P=0.06 | P=0.97 | P=0.03 |
| Primary outcome | ||||||
| No. of patients with data available | 30 (100)* | 23 (100)† | 25 (96)‡ | |||
| Effective sedation without side effects, n (%) | 1 (3) | 2 (9) | 7 (28) | P=0.57 | P=0.02 | P=0.15 |
| Sedative effect of propofol | ||||||
| Adequate pre-intubation sedation level, n (%) | 7 (23) | 7 (30) | 24 (92) | P=0.75 | P<0.001 | P<0.001 |
| Quality of intubation | ||||||
| No. of patients with data available | 3 (10) | 7 (30) | 19 (73) | |||
| Good quality of intubation | 1 (33) | 3 (43) | 18 (95) | P=0.18 | P=0.02 | P=0.003 |
| Effective sedation | ||||||
| No. of patients with data available | 28 (93) | 23 (100) | 21 (81) | |||
| Effective sedation, n (%) | 1 (4) | 3 (13) | 18 (86) | P=0.21 | P<0.001 | P<0.001 |
| Hypotension | ||||||
| No. of patients with data available | 24 (80) | 21 (91) | 26 (100) | |||
| Occurrence of hypotension, n (%) | 15 (63) | 11 (52) | 16 (62) | P=0.55 | P=1.0 | P=0.57 |
| Volume resuscitation, n (% of hypotensive patients) | 7 (47) | 4 (36) | 12 (75) | P=0.86 | P=0.18 | P=0.09 |
*Both patients with missing data on effective sedation had side effects and all six patients with missing data on side effects had insufficient sedation. Therefore, a conclusion on the primary outcome could be drawn for all 30 patients.
†Both patients with missing data on side effects had inadequate sedation and, therefore, a conclusion on the primary outcome could be drawn on all 23 patients.
‡In four patients with missing data on effective sedation, side effects were present and in only one patient both data on effective sedation and side effects were missing. Therefore, a conclusion on the primary outcome could be drawn in 25 out of 26 patients.