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A RANDOMISED CONTROLLED MULTICENTRE TRIAL
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distributed, continuous variables an independent Student’s t-test will be used, and the
variables will be presented as mean ± standard deviation (SD). Not normally distributed
data will be compared using the Mann-Whitney U-test where appropriate, and data will
be presented by the median and interquartile range (IQR). For categorical variables, cross
tabulation and the Pearson`s chi-squared test will be applied and variables will be allegorised
as number and/or percentage of the total. To compare the continuous measurements of
HR, NIPD, and SpO
2
between both groups, the area under the curve (AUC) for each value
will be calculated over the different measurement time points during the procedure. A
p-value< 0.05 will be considered statistically significant. Confidence intervals will be
mentioned where appropriate.
Ethical approval
This trial is conducted in accordance with the protocol and in compliance with the moral,
ethical, and scientific principles governing clinical research as set out in the Declaration
of Helsinki (1989) and Good Clinical Practice (GCP). It is registered in the Nederland’s Trial
Register (NTR5486). Ethical approval was obtained from the Medical Ethics Committee of
the Academic Medical Centre, Amsterdam, the Netherland (NL). The National Authority, the
Central Committee on Research Involving Human Subjects (CCMO), performed a marginal
review and there were no objections to perform this study (NL53999.018.15).
DISCUSSION
Propofol combined with an opioid replaces more and more benzodiazepines for sedation
during ERCP. It is in themeantime the standard sedative agent due to a better titration of the
different sedation levels, shorter recovery time, and more patient satisfaction. However, a
serious drawback of propofol/opioid sedation is that sedation level can rapidly chance from
moderate to deep sedation, or even to general anaesthesia. Here, skilled airway support,
which is not easy to perform in the prone position, may be required to prevent hypoxaemia.
Cote et al. showed that in 12.8% (n=102) patients hypoxaemia occurred during propofol
sedation, although propofol was administered by trained anaesthesia nurses.
10
In 14.4%
of the patients, tactile airway manoeuvres were necessary. Minimising respiratory risks is
therefore important, to make sedation safer. A possible approach can be, to reduce the
propofol dosage using the combination with other substances.
Previous studies usedpropofol combinedwithmidazolamfor ERCP sedation.
11,12
Thismethod
significantly reduced the total amount of propofol required for sedation. Nevertheless, the
synergistic sedation effects of both drugs increased the likelihood of respiratory depression
and prolonged recovery timewithout any analgesic effect. Esketamine offers the advantages
of minimising these side effects, making optimal use of the concept of synergy whilst being