Susanne Eberl

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Chapter 10

Secondary Endpoints

As secondary endpoints the total procedure time (time between insertion and removal of

the bronchoscope), sedation induction time (time between start of propofol/remifentanil

infusion and insertion of the bronchoscope), time to sedation recovery (time between

removal of the bronchoscope and arrival in the recovery room), time to discharge (time

between removal of thebronchoscope anddischarge fromthe recovery room), total amount

of propofol and remifentanil, the number of successful BT activations per procedure, and

the number of times backup by the anaesthesiologist on call was needed were recorded.

After finishing the procedure, the bronchoscopist scored the OAA/S scale to assess the

overall level of sedation during the procedure.

Sedation-related adverse events

Sedation-related adverse events were defined as a decline in SpO

to < 90% during > 30 s,

hypotension or hypertension (blood pressure decreased/elevated > 20% of baseline blood

pressure and requiring intervention), or respiratory arrest.

Statistical methods

Descriptive statistics were performed, and results were expressed as means (± standard

deviations [SD]) in case of a normal distribution of variables, and medians (interquartile

ranges [IQR]) were used for variables with a skewed distribution. Categorical data were

expressed as numbers and percentages. Analysis was performed using SPSS software

version 22 (IBM, Armonk, NY, USA).

Statement of ethics

For the current prospective observational cohort sedation trial, ethical approval was

obtained for the sedation questionnaires from the Medical Ethics Committee of the AMC,

Amsterdam, the Netherlands (NL45394.018.13). All patients provided written informed

consent.

RESULTS

From August 2014 to April 2016, 13 patients underwent a total of 35 BT procedures. Three

out of the 35 BT procedures were performed under general anaesthesia. The other 32

procedures were performed under TCI propofol and remifentanil sedation and used for

analysis. Baseline patient characteristics are summarised in Table 1.