Ellen de Kort

113 Propofol for intubation in neonates 7 patients. Therefore, an optimal dose as predefined in the primary outcome in these two groups was not established. The study was prematurely terminated, therefore, in consultation with the data safety monitoring committee. Primary outcome Dose-finding was only completed in groups 3 and 5, without finding an optimal propofol dose. The results of the dose-finding approach in sequential patients in groups 3 and 5 are presented in Figure 2. In both groups, starting doses of 1.0 and 1.5 mg/kg almost never led to effective sedation. A starting dose of 2.0 mg/kg led to effective sedation in many patients, but also led to a high incidence of hypotension, even after confirming this dose in another five patients per group. The dose, therefore, was decreased to 1.75 mg/kg, which did not provide effective sedation in the majority of patients in both groups. Secondary outcomes In the entire study population, effective sedation without side effects was achieved in only 12 patients (13%). Additional propofol was administered to 65 patients (71%) and the median cumulative propofol dose for successful intubation was 3.0 mg/kg (range 1.0 to 6.0 mg/kg, IQR 2.0-3.75). Propofol starting doses of 1.0, 1.5 and 2.0 mg/kg were used in further in-depth analyses. There were no differences in patient characteristics between the three groups, with the exception of PNA (Table 2). This was lower in the 2.0 mg/kg dosing group, due to the higher inclusion numbers at younger postnatal ages. A starting dose of 2.0 mg/kg much more often led to effective sedation than starting doses of 1.0 and 1.5 mg/kg. The incidence of hypotension, however, was not different between the three starting doses. Sufficient MBP data after propofol administration were available for 82 patients (90%). Propofol-induced hypotension occurred in 48 patients (59%). Of these, 26 patients (54%) were treated with volume resuscitation. Therapy with inotropes was started in nine patients (10%) at a median of 298 min after propofol administration (IQR 125-917 minutes). In seven of these patients, inotropes were started >2 hours after the start of propofol administration. In two other patients, inotropes were started within 2 hours and the hypotension is probably attributable to propofol. Comparison of MBP data before and after propofol was possible in 80 patients (88%). MBP decreased with a median of 34% (95% CI 36.5 to 29.1%) compared to baseline MBP. The lowest MBPwas measured at a median of 21 min (95% CI 19.3 to 26.2 min).