A Phase 3 interventional study of Propofol and Ketamine-Propofol in Sedation, sponsored by Achim Schmitz. Completed at 1 site in Switzerland. Open to participants aged 3 Months to 10 Years. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Achim Schmitz · Phase 3, Interventional, and Other
Children \< 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are
both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow.
Hypothesis:
Achim Schmitz is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Propofol 10 mg/h as maintenance infusion
Drug: Propofol
Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion
Drug: Ketamine-Propofol
Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion
Recovery time
Time from end of MRI until recovery defined as Aldrete Score = 10
Time frame: 1 - 3 hours post anaesthesia
Demission time
time until demission
Time frame: 1 - 4 hours post anaesthesia
PONV
Postoperative nausea or vomiting
Time frame: 24 hours
Cerebral perfusion
noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI
Time frame: first 10 minutes of MRI
Incidence of emergence delirium
Time frame: 1 - 4 hours post anaesthesia
Quality of sedation
Extra Propofol doses and total amount of Propofol required, movement artefacts
Time frame: during MRI, on the average 45 minutes
respiratory and cardiovascular adverse events
Time frame: during sedation, on the average 60 minutes
Ran from Feb 2018 to primary completion in Jun 2024, 75 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketofol
Achim Schmitz