drugset / Trial / NCT01519154

Sedation MRI - Propofol Versus Propofol-Ketamin in Children

NCT01519154

Phase 3 Completed 347 enrolled Achim Schmitz
RandomizedParallel-groupTriple-blindOther

Summary

Children \< 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are 1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h 2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow. Hypothesis: 1. reduces recovery time compared to propofol mono sedation 2. combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation 3. combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation

Timeline

Start
2018-02-09
Primary completion
2024-06-04
Completion
2024-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 1 mg/kg
Comparator Propofol Small molecule 10 mg

Indications

No indication recorded.