Susanne Eberl

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Chapter 11

ABSTRACT

Background:

Endoscopic retrograde cholangiopancreatography (ERCP) is a gastrointestinal

procedure

that requires a relatively motionless patient during the intervention. Deep

sedation by intravenous propofol combined with an opioid has recently become

the preferred sedation technique. The drawback of this technique can be serious

cardiorespiratory depression. Esketamine has hypnotic, analgesic, and sympathomimetic

effects. Our assumption is that a combination of propofol with esketamine reduces the

dosage of individual drugs, thereby minimising sedation side effects while keeping the

same satisfaction level of patients and endoscopists.

Methods/design:

The study will be performed as a randomised controlled multicentre trial.

Patients undergoing ERCP, ≥ 18 years, ASA classification I – III will be randomised after written

informed consent to group K (propofol/esketamine) or to group A (propofol/alfentanil).

Primary outcome, reflecting effectiveness of sedation, is the total dose of propofol.

Secondary outcome parameters are patients` and endoscopists` satisfaction with the

procedure and the number of sedation related cardiorespiratory events. Data - regarding

sedation related incidents - are collected by recording of oxygen saturation (SpO

respiratory rate (RR), end-tidal CO

(etCO

), heart rate (HR), arrhythmias (ECG), and non-

invasive blood pressure (NIBP) measurements. Satisfaction parameters are collected by

means of questionnaires before and after the procedure and on the following day.

Discussion:

Esketamine is known for its effective anaesthetic and analgesic effects

maintaining spontaneous breathing and airway reflexes. Due to an increase in sympathetic

tone, hypotension and cardiac depression is less common. Unfortunately, esketamine is

also known for its psychotomimetic effects. We aim to demonstrate that the combination

of esketamine with propofol for sedation in patients subjected to ERCP interventions is

nevertheless superior to a combination of propofol with an opioid.