An interventional study of Propofol and General anesthesia in Anesthesia, ERCP and Safety, sponsored by Erasme University Hospital. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Erasme University Hospital · Not applicable, Interventional, and Prevention
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.
What may be the benefits of general anaesthesia? In one retrospective study of more than 1000 patients, the ERCP failure rate with general anaesthesia was half compared to that observed with moderate sedation (7% versus 14%), with most failures resulting from inadequate sedation. It has also been reported that complication rates associated with therapeutic interventions during ERCP may be significantly lower when general anaesthesia is used, perhaps because the absence of patient movement makes the procedure technically less difficult. When general anaesthesia is administered for ERCP, the airway is protected by endotracheal intubation which may decrease risk for broncho-aspiration in some patients, although this measure has not been demonstrated to be effective in patients at risk during digestive endoscopy.
However, aspiration at the time of in/ex-tubation as well as micro-aspiration of contaminated upper airway secretions along leaks and defects of the tracheal cuff seal is not excluded if standard endotracheal tubes are used.
What may be the harms of general anaesthesia? Intubation and extubation manoeuvres may prolong endoscopic room occupation time, post-anaesthesia care unit stay may be longer and about 30 to 70% of patients will suffer from sore throat (this is reduced if lidocaine is used).
Furthermore, orotracheal intubation may induce short time hemodynamic changes related to laryngoscopy.
What may be the benefits of deep sedation? The main advantage of sedation is probably the faster turnover in the intervention room. In the sole practice survey of anesthesiologists for endoscopy that is available, 81% of anaesthesiologists stated that they were using sedation, not general anesthesia, for ERCP.
Deep sedation with propofol during digestive endoscopy has been shown to be superior to moderate sedation with a combination of benzodiazepine plus opioid in many aspects, including better patient cooperation, shorter recovery time and lower number of desaturation events.
In Switzerland, sedation during ERCP is obtained using benzodiazepines or propofol in similar proportions of cases and, when propofol is used, it is administered by the endoscopist or nurse in two thirds of cases and by the anaesthesiologist in one third of cases.
Evidence from prospective studies suggests that complex procedures, including therapeutic ERCP, may be performed safely under deep sedation without tracheal intubation using propofol, even in high-risk patients.
What may be harms of deep sedation? In a large study including nearly 10'000 patients, adverse events were observed in 1.4% of patients sedated using propofol. In that study, adverse events were defined as premature termination of the procedure due to sedation-related events (most often related to hypoxemia) or the need for assisted ventilation or, very rarely, admission to intensive care unit.
Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Remifentanil 1ng/ml throughout the procedure. Propofol administration starts at an initial (estimated plasma) target concentration of 1,5 microg/ml. Propofol administration is adjusted to level 1 or 2 on the modified observer's assessment of alertness/sedation scale. The propofol infusion will be increased stepwise by 0,5 microg/ml every 1 minute until loss of consciousness. Propofol is continued while maintaining spontaneous ventilation without assistance and systolic blood pressure ≥ 60 % of baseline systolic blood pressure.
Drug: Propofol
General anesthesia will be induced with target controlled infusion (TCI) of propofol and remifentanil as in the group "deep sedation". Suxamethonium (succinylcholine) will be used to facilitate intubation. Endotracheal tube balloon pressure will be controlled during the procedure. Ventilation will be assisted using 40% oxygen in air mixture and mechanically controlled using an anaesthetic ventilator.
Other: General anesthesia
ERCP success rate
The primary study outcome will be a comparison between patient allocation groups and the percentage of completely successful ERCP. Success of ERCP is defined as achieving both high completion and low adverse event rate.
Time frame: 24 hours
Success of ERCP in subgroups of patients
Secondary outcome will include a comparison between patient allocation groups of the success of ERCP in subgroups of patients (difficulty grade of ERCP = 2 or 3, ASA score = 4)
Time frame: 24 hours
composite "efficacy-safety" index
A composite "efficacy-safety" index will be calculated by adding the incidence, within 30 days of study ERCP, of repeat bilio-pancreatic procedure, major complication, re-hospitalisation and death.
Time frame: 30 days
patient satisfaction
Time frame: 30 days
clinician satisfaction
Time frame: 30 days
duration of patient recovery
Time frame: 30 days
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Erasme University Hospital