RCT of Efficacy and Safety of Sedation Compared to General Anesthesia for ERCP
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
There is a worldwide trend to minimally invasive interventions, which results in increasing
numbers of interventions performed outside of the operating room. Currently, approximately 12
to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this
anaesthetic activity is increasing.
Many of these interventions need supplementary comfort measures to have relaxed patients and
high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed
>50,000 times per year in the U.S.,and is a typical minimally invasive intervention that
needs patient sedation.
There is a controversy about the optimal comfort intervention in minimally invasive
interventions and in particular in ERCP. Two different approaches to insure patients' comfort
have been proposed: general anaesthesia with endotracheal intubation and mechanical
ventilation or sedation with spontaneous ventilation.
Well-performed studies on sedation versus general anaesthesia using a randomized controlled
trial design with observer blinding will contribute to improve the decision-making for the
optimal comfort measures in minimally invasive procedures. At our knowledge such a randomized
controlled trial has not been reported before. The investigators hypothesize that deep
sedation without tracheal intubation will achieve similar success rates for ERCP as general
anaesthesia and will have similar rates of harmful postoperative effects.
The primary aim of this trial is to demonstrate that the success rate of ERCP is not inferior
in patients randomized to deep sedation without orotracheal intubation vs general anesthesia
with orotracheal intubation. Secondary aims include a comparison between randomization groups
of patient safety, patient and endoscopist satisfaction, duration of patient recovery and of
anesthesia procedure.