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

NCT02046590 | Terminated

• 1 other identifier: B406201318623
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; ERCP; Safety; Efficacy

Keywords

Propofol; remifentanil; safety; gastro-intestinal; ERCP; minimally invasive; intubation; ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (1)

• Success of ERCP in subgroups of patients

  24 hours

Other Outcomes (4)

• composite "efficacy-safety" index

  30 days

• patient satisfaction

  30 days

• clinician satisfaction

  30 days

Study Arms (2)

Deep Sedation

ACTIVE COMPARATOR

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 Anaesthesia

ACTIVE COMPARATOR

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

Interventions

Propofol DRUG

Deep Sedation

General anesthesia OTHER

General Anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Propofol; Anesthesia, General

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia; Anesthesia and Analgesia

Study Officials

• Vincent Huberty, MD

  Gastroenterology Department Erasme Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: February 1, 2014
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

BE (1)