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141

A RANDOMISED CONTROLLED MULTICENTRE TRIAL

11

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.