Comparison of different forms of sedation during endoscopie of the bile ducts
Completed
- Conditions
- sedation, esketamine, ERCP
- Registration Number
- NL-OMON22136
- Lead Sponsor
- Department of Anesthesiology and , Department of Gastroenterology & Hepatology, Academic Medical Centre,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 166
Inclusion Criteria
The patients must comply with the following criteria in order to be eligible to participate in this clinical study:
Age range ¡Ý 18 years
Exclusion Criteria
Patient will be excluded if the following criteria in the patients¡¡Â medical history are applicable:
Age range < 18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine the effectiveness of propofol/esketamine compared to propofol/alfentanil sedation, both administered by anaesthetic nurses trained in procedural sedation and analgesia (PSA). Considering effectiveness there are four aspects to determine the effectiveness of the propofol/esketamine regime. First, will the synergistic combination of propofol and esketamine result in a dosage reduction of propofol? Secondly, are the levels of sedation and analgesia (without opioids) sufficient to perform the procedure? Thirdly, are patients more satisfied by the combination propofol/esketamine concerning side effects? Fourth, is recovery time shorter?
- Secondary Outcome Measures
Name Time Method Secondary objectives concern patient safety. Safety is thereby a synonym for a reduction in pulmonary and cardiovascular incidents and complications (hypotension, respiratory depression, hypoxemia) that could be attributed to the respective sedation regime.