Ellen de Kort

45 Remifentanil for INSURE in preterm newborns 3 Ethics committee approval We received a waiver for ethical approval of the observational trial according to the Dutch Law of Research with Humans (No. 2014.435; Medical Ethical Committee, Erasmus Medical Center, Rotterdam, the Netherlands). RESULTS Characteristics of included patients Due to insufficient sedation and a high rate of side effects, the use of remifentanil was terminated after the inclusion of 14 patients: 5 patients in study period 1 and 9 patients in study period 2. The baseline characteristics of the study patients and outcomes in study period 1 and study period 2 are reported in Table 2. Primary outcome measures Adequate sedationwas by the combination of three key components: adequate sedation score, adequate intubation conditions and the absence of side effects. This was achieved in only two patients (14%) of our total study population. In study period 1, two patients had an adequate sedation score but one of them had inadequate intubation conditions despite this score. In the remaining three patients the sedation score was inadequate. Two of them were intubated with propofol while the other was intubated despite the inadequate sedation score. None of the patients developed chest wall rigidity. In summary, adequate sedation based on the three key components was only achieved in one patient in study period 1. In study period 2 adequate sedation scores after remifentanil were achieved in six patients. However, only one patient also had adequate intubation conditions and no side effects. One patient had inadequate intubation conditions and four patients developed chest wall rigidity. In two of these latter patients, intubation failed or was never tried and propofol was administered. The sedation score was inadequate in three patients. In two of these patients propofol was used and one patient was intubated despite an inadequate sedation score. Two of these three patients developed chest wall rigidity. In summary, in study period 2 adequate sedation based on the three key components was also only achieved in one patient. Chest wall rigiditywas a frequently reported side effect, occurring in six patients (43%), all in study period 2 (67% of patients in study period 2). Chest wall rigidity always occurred directly after the administration of remifentanil and never after the administration of propofol. No other side effects such as hypotension were identified.