disorders of the gallblader and bile ducts Hepatobiliary disease
Conditions
Interventions
Patients will be randomized to an esketamine and propofol regime
(interventional arm) or to an alfentanil/propofol regime (control arm) and
studied during the endoscopic procedure.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The patients must comply with the following criteria in order to be eligible to participate in this clinical study:;Age range * 18 years ASA classification I * III Planned ERCP/EUS procedure Written informed consent
Exclusion criteria
Exclusion criteria: Patient will be excluded if the following criteria are applicable: Age range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are the total dosage of propofol, recovery time, and satisfaction with the procedure of patients and endoscopists. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters concerning the safety aspect, are recording of oxygen saturation (SpO2) measured by pulse oximetry, respiratory rate (RR), exhaled CO2 (capnography), heart rate (HR), arrhythmias (ECG) and non-invasive blood pressure (NIBP). These vital parameters will indicate pulmonary and cardiovascular incidents, experienced by the patient during sedation. | — |
Countries
Netherlands
Outcome results
None listed