Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Ketamine

Brief 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

Intervention / Treatment

  • Propofol (DRUG)
    Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
  • Ketamine-Propofol (DRUG)
    Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion

Condition or Disease

  • Sedation

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Months to 10 Years
    Enrollment: 347 (ACTUAL)
    Funded by: Other
    Allocation: Randomized

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Mar 01, 2012
    Primary Completion: Nov 01, 2014 ACTUAL
    Completion Date: Nov 01, 2014 ACTUAL
    Study First Posted: Jan 26, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 26, 2014

    Sponsors / Collaborators

    Lead Sponsor: Achim Schmitz
    Responsible Party: Achim Schmitz

    Location

    Zürich, Switzerland

    Participant Groups

    • Propofol 10 mg/h as maintenance infusion

    • Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion

    Eligibility Criteria

    Sex: All
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Time from end of MRI until recovery defined as Aldrete Score = 10

    Secondary Outcomes

    • time until demission

    • Postoperative nausea or vomiting

    • noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI

    • Incidence of emergence delirium 1 - 4 hours post anaesthesia

    • Extra Propofol doses and total amount of Propofol required, movement artefacts

    • respiratory and cardiovascular adverse events during sedation, on the average 60 minutes

    More Details

    NCT Number: NCT01519154
    Other IDs: KEK-ZH Nr. 2011-0190
    Study URL: https://clinicaltrials.gov/study/NCT01519154
    Last updated: Sep 29, 2023