Sedation MRI – Propofol Versus Propofol-Ketamin in Children

Overview

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

Full Title of Study: “Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2014

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Propofol
    • Propofol 10 mg/h as maintenance infusion
  • Experimental: Ketamine-Propofol
    • Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion

Clinical Trial Outcome Measures

Primary Measures

  • Recovery time
    • Time Frame: 1 – 3 hours post anaesthesia
    • Time from end of MRI until recovery defined as Aldrete Score = 10

Secondary Measures

  • Demission time
    • Time Frame: 1 – 4 hours post anaesthesia
    • time until demission
  • PONV
    • Time Frame: 24 hours
    • Postoperative nausea or vomiting
  • Cerebral perfusion
    • Time Frame: first 10 minutes of MRI
    • noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI
  • Incidence of emergence delirium
    • Time Frame: 1 – 4 hours post anaesthesia
  • Quality of sedation
    • Time Frame: during MRI, on the average 45 minutes
    • Extra Propofol doses and total amount of Propofol required, movement artefacts
  • respiratory and cardiovascular adverse events
    • Time Frame: during sedation, on the average 60 minutes

Participating in This Clinical Trial

Inclusion Criteria

  • MRT in deep sedation – outpatient – > 3 months to <= 10 years Exclusion Criteria:

  • tracheal intubation required – contraindication of ketamine or propofol – additional painful procedure requiring analgesics

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Achim Schmitz
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Achim Schmitz, Principal Investigator – University Children’s Hospital, Zurich
  • Overall Official(s)
    • Achim J Schmitz, MD, Principal Investigator, University Children’s Hospital, Zurich

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