Patients undergoing ERCPs under propofol sedation combined with ketamine or alfentanil given by trained anesthesia nurse.
Conditions
Interventions
Trade Name: Rapifen
Product Name: Alfentanil hydrochlorid
Product Code: no
Pharmaceutical Form: Infusion
Trade Name: Ketanest S
Product Name: esketamine
Product Code: n.a.
Pharmaceutical Form: Infusi
Sponsors
AMC
Eligibility
Sex/Gender
All
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 procedure Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: Patient will be excluded if the following criteria are applicable: Age range < 18 years ASA classification IV and V Allergic reaction to planned medication in the patients’ medical history Unregulated hypertension History of malignant hypertension Significant ischaemic heart disease Mentally disordered History of psychological problems or psychiatric disease Use of drugs that affect the central nervous system Substance abuse Chronic pain Pregnancy Seizure disorders Increased intracranial pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives reflect the effectiveness of coadministration of propofol and esketamine. Will this combination of propofol and ketamine allow for a reduction in the total dosage of propofol and so result in faster recovery time with less side effects? Is the level of sedation and analgesia sufficient to perform the procedure? Are patients more satisfied? ;Secondary Objective: Which form of sedation is safer for the patient in regard to respiratory and cardiovascular problems? Surrogate parameters of pulmonary and cardiovascular problems are oxygen saturation (SO2) measured by pulse oximetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure measurement (NIBP).;Primary end point(s): Main study parameters, reflecting effectiveness of esketamine are the total dosage of propofol, recovery time, and satisfaction with the procedure of patients and endoscopists. ;Timepoint(s) of evaluation of this end point: Satisfaction levels are measured by means of questionnaires pre- and post procedure (30min post) and in case of the patient on the following day. Dosage of propofol and recovery time is documented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters include in patients measurement of oxygen saturation (SO2) measured by pulseoxymetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (noninvasive blood pressure measurement, NIBP). These parameters are surrogate parameters of pulmonary and cardiovascular problems, experienced by the patient during sedation.;Timepoint(s) of evaluation of this end point: Measurements take place during procedure and recovery period. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial information
AMC
Outcome results
None listed