Patients undergoing therapeutically esophageal interventions under sedation (dexmedetomidine or propofol/alfentanil) given by trained anesthesia nurse.
Conditions
Interventions
Trade Name: Propofol-Lipuro 10mg/ml
Product Name: Propofol-Lipuro
Pharmaceutical Form: Infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Concentration unit: mg/ml milligram(s)/millilitre
Co
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 Patients, undergoing elective oesophagus intervention 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Age range < 18 years ASA classification IV and V Allergic reaction to planned medication in the patients’ medical history Unregulated hypertension Hypovolemia or hypotension (SBP <80 or MAP <50) Sever bradycardia (heartrate < 50) and / or related bradydysrhytmias (e.g. advanced heart block) Impaired ventricular function (EF <30%) GFR less than 15ml/min or undergoing hemodialysis End stage liver disease Substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Which regime minimizes patient flow time (induction time + procedure time + recovery time)? ;Primary end point(s): Main study parameters are the experiences (e.g. satisfaction levels reached) made by patients and gastroenterologist during sedation. We will also measure sweat production by a sweat conduction monitor as a mark for patients stress level during endoscopy. ;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. Sweat conductance monitoring will be used during the procedure and recovery. ;Main Objective: How is the experience (e.g. satisfaction levels, pain score, sedation score reached) of patients and endoscopist with sedation by means of dexmedetomidine or propofol/alfentanil during oesophagus interventions? Are there differences between different sedation regimes in patients undergoing oesophageal intervention? | — |
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 (non-invasive 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