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INTRODUCTION AND OUTLINE OF THE THESIS
Chapter 11
focuses on esketamine - an old and at the same time new medicinal option
for deep sedation. Esketamine is a well-known drug with extensive use in the prehospital
environment and emergency and critical care departments over the last years. Our
still on-going study investigates deep procedural sedation for endoscopic retrograde
cholangiopancreatography (ERCP) - an endoscopic intervention that requires a relatively
motionless patient to facilitate this difficult procedure. In the last years, deep sedation
with propofol combined with an opioid has become the standard sedation approach.
Unfortunately, drawback of this combination is often serious cardiorespiratory depression.
Esketamine, the s-enantiomer of ketamine and also a non-competitive N-methyl-D-
aspartate (NMDA)-receptor antagonist and opioid receptor agonist, is known for its
effective anaesthetic and analgesic effects maintaining spontaneous breathing and airway
reflexes.
31,32,33
Due to an increase in sympathetic tone hypotension and cardiac depression
after ketamine application is less common.
34
Patients are randomised to group K (propofol/
esketamine) or to group A (propofol/alfentanil). Primary outcome is the dosage of propofol
needed for adequate sedation. Patients` and endoscopists` experiences are measured
by means of questionnaires before and after the procedure and on the following day.
Haemodynamic and respiratory parameters, and incidents are recorded as surrogate
parameters for patient safety.
We aim to demonstrate in this randomised controlled multicentre trial 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.
In daily practice, moderate and deep sedation is usually realised by drug therapy. But there
are other non-medicinal options like acupuncture that can provide or support sedation
measures.
Chapter 12
focuses on acupuncture, which has been used since a long time for multiple
indications. Well known is the role of acupuncture in pain treatment.
35,36,37
However, only few
studies are published with respect to its use during sedation for endoscopic gastrointestinal
interventions.
We hypothesised in this study
38
that “verum” acupuncture causes not only analgesia, but
also has a sedative effect that will allow to reduce the total dosage of propofol necessary
for an adequate sedation level during colonoscopies. For this trial, 153 patients were after
randomisation allocated to receive electro-acupuncture (EA), sham-acupuncture (SA), or
placebo-acupuncture (PA) combined with deep sedation performed with propofol and
alfentanil. In the EA group, patients received verum-acupuncture needles unilateral on
three points. We chose points, which are relevant for sedation and for abdominal distension:
Pericardium 6 (P6), Stomach 36 (ST36), and Large Intestine 4 (LI4). Group SA got sham-