NCT01519154

Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Achim Schmitz · Academic / Other
• Sex: All
• Age: 3 Months – 10 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Propofol	Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
DRUG	Ketamine-Propofol	Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion

Timeline

• Start date: 2018-02-09
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2012-01-26
• Last updated: 2024-12-20

Locations

1 site across 1 country: Switzerland