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A RANDOMISED CONTROLLED MULTICENTRE TRIAL
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BACKGROUND
Endoscopic retrograde cholangiopancreatography (ERCP) is a complex, often painful
gastrointestinal procedure. It is used for both, diagnostic purposes in biliary and pancreatic
diseases and also for therapeutically interventions such as sphincterotomy, gallstone
extraction, and biliary and pancreatic duct stenting. Because any movement of the patient
could importantly affect success of the ERCP, procedures are usually performed under deep
sedation or even general anaesthesia with the patients in semiprone or prone position.
1-3
Over the last decade the combination of propofol and an opioid has become the preferred
sedative regime during ERCP in many countries, despite known side effects, such as
hypotension and respiratory depression. Opioids, especially when used in combination
with sedative-hypnotics, can not only aggravate clinically significant respiratory depression
but also increase the incidence of postoperative nausea and vomiting.
Esketamine, the s-enantiomer of ketamine, is not only a well-known sedative but also has
strong analgesic properties. Furthermore, its sympathomimetic qualities can counteract
the haemodynamic depression of propofol and therefore reduce the risk of cardiovascular
and respiratory depression during sedation. Esketamine could thus be a safer additive
to propofol than opioids to achieve a sufficient depth of sedation with less negative
cardiopulmonary side effects due to dosage reduction of propofol and omission of opioids.
A potential problem concerning esketamine could be its psychotomimetic effects, such as
visual disturbances, vertigo, or nausea that could compromise patient satisfaction. There is
still little evidence for an improved safety profile of a combination of propofol/esketamine,
and it is still open to discussion whether esketamine psychotomimetic effects play a
significant role in out patient treatment.
METHODS/DESIGN
Aim of the study
We hypothesise that procedural sedation with propofol and esketamine will reduce the
number of sedation related side effects during ERCP with superiority to standard propofol/
alfentanil sedation and thus demonstrate a higher safety and satisfaction profile as the
former combination.
To test this hypothesis, we compare two groups. Group K receives propofol/esketamine
sedation; group A gets propofol/alfentanil sedation during ERCP.
Both groups receive standard deep sedation with propofol target controlled infusion (TCI)
provided by specialised sedation anaesthesia nurses.