RCT of Efficacy and Safety of Sedation Compared to General Anesthesia for ERCP

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasme University Hospital
• Treatments: Anesthetics; Propofol; Remifentanil

Criteria

Inclusion Criteria:

• Patient with scheduled therapeutic ERCP

• Written informed consent for the study protocol obtained from the patient or his/her legal representative

• Anaesthetist available for the procedure

Exclusion Criteria:

• Mechanically ventilated patients before the procedure

• Baseline oxyhemoglobin saturation < 90%

• Baseline systolic blood pressure < 90 mm Hg

• American Society of Anaesthesiologists (ASA) physical score 5 (Table 1)

• Age < 18 years

• Pregnancy

• Emergency procedure

• Absence of fasting ≥ 6 hours for solids and ≥ 2 hours for clear liquids

• Contraindication to any study drug

• Short, thick neck or trismus that may complicate airway rescue

• Previous documented difficult airway intubation

• Obstructive sleep apnea

• Severe swallowing disorders with documented broncho-aspiration

• Bowel obstruction

• Inclusion in the present protocol during the 30 preceding days