Recruitment

Recruitment Status
Recruiting

Inclusion Criterias

Written informed consent for the study protocol obtained from the patient or his/her legal representative
Patient with scheduled therapeutic ERCP
Anaesthetist available for the procedure
Written informed consent for the study protocol obtained from the patient or his/her legal representative
Patient with scheduled therapeutic ERCP
Anaesthetist available for the procedure

Exclusion Criterias

Mechanically ventilated patients before the procedure
Baseline systolic blood pressure < 90 mm Hg
Bowel obstruction
...
Mechanically ventilated patients before the procedure
Baseline systolic blood pressure < 90 mm Hg
Bowel obstruction
Contraindication to any study drug
American Society of Anaesthesiologists (ASA) physical score 5 (Table 1)
Age < 18 years
Emergency procedure
Short, thick neck or trismus that may complicate airway rescue
Previous documented difficult airway intubation
Severe swallowing disorders with documented broncho-aspiration
Absence of fasting ≥ 6 hours for solids and ≥ 2 hours for clear liquids
Baseline oxyhemoglobin saturation < 90%
Obstructive sleep apnea
Inclusion in the present protocol during the 30 preceding days
Pregnancy

Summary

Conditions
  • Anesthesia
  • Efficacy
  • ERCP
  • Safety
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 re...

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.

Inclusion Criterias

Written informed consent for the study protocol obtained from the patient or his/her legal representative
Patient with scheduled therapeutic ERCP
Anaesthetist available for the procedure
Written informed consent for the study protocol obtained from the patient or his/her legal representative
Patient with scheduled therapeutic ERCP
Anaesthetist available for the procedure

Exclusion Criterias

Mechanically ventilated patients before the procedure
Baseline systolic blood pressure < 90 mm Hg
Bowel obstruction
...
Mechanically ventilated patients before the procedure
Baseline systolic blood pressure < 90 mm Hg
Bowel obstruction
Contraindication to any study drug
American Society of Anaesthesiologists (ASA) physical score 5 (Table 1)
Age < 18 years
Emergency procedure
Short, thick neck or trismus that may complicate airway rescue
Previous documented difficult airway intubation
Severe swallowing disorders with documented broncho-aspiration
Absence of fasting ≥ 6 hours for solids and ≥ 2 hours for clear liquids
Baseline oxyhemoglobin saturation < 90%
Obstructive sleep apnea
Inclusion in the present protocol during the 30 preceding days
Pregnancy

Locations

Brussels, 1070
Brussels, 1070

Tracking Information

NCT #
NCT02046590
Collaborators
Not Provided
Investigators
  • Principal Investigator: Vincent Huberty, MD Gastroenterology Department Erasme Hospital
  • Vincent Huberty, MD Gastroenterology Department Erasme Hospital