Effects and side effects of analgosedation Q20 Q21 Q22 Q23 Q24 Q25 Q26
Conditions
Interventions
Group 1: Analgesia by application of local anaesthesia, sedation by application of propofol
measurement of vital parameters (heart rate, niBP and periphal saturation every 5 to 10 minutes) and blood work (pH, pCO2, lactate)
complications during cardiac catheterization
nausea and vomiting during recovery from sedation
Group 2: Analgesia by application of local anaesthesia, sedation by application of 4-hydroxybutanoic acid (gamma-hydroxybutyric acid)
nausea and vomiting during recovery from sedation
Sponsors
Klinik für Pädiatrische KardiologieUniversitätsklinikum des Saarlandes
Eligibility
Sex/Gender
All
Age
4 Weeks to 18 Years
Inclusion criteria
Inclusion criteria: Patients aged between one month and 18 years with the need for a diagnostic and/or interventional cardiac catheterization.
Exclusion criteria
Exclusion criteria: Missing consent of the parents or the legal representatives; infectious disease at the moment of cardiac catheterization or to one week prior to examination; history of known allergic or incompatible reactions to the planned medication; anomalies of the airways or acute or chronic diseases of the respiratory tract which may lead to intubation or other complications of the airways during the sedation; pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of cardiac catheterization; discontinuation of cardiac catheterization or necessity for a switch of the method of analgosedation | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in laboratory parameters (e. g. pC02, lactate), quality of sedation (documentation of unrest, complications, necessary interventions and additional application of sedatives), incidence of complications during and after sedation | — |
Countries
Germany
Contacts
Public ContactHarald Sauer
Klinik für Pädiatrische KardiologieUniversitätsklinikum des Saarlandes
Outcome results
None listed