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Sedation MRI - Propofol Versus Propofol-Ketamin in Children

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ClinicalTrials.gov Identifier: NCT01519154
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Achim Schmitz, University Children's Hospital, Zurich

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

Condition or disease Intervention/treatment Phase
Sedation Drug: Propofol Drug: Ketamine-Propofol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
Study Start Date : March 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Propofol
Propofol 10 mg/h as maintenance infusion
Drug: Propofol
Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
Experimental: Ketamine-Propofol
Additional Ketamine at induction, Propofol 5 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



Primary Outcome Measures :
  1. Recovery time [ Time Frame: 1 - 3 hours post anaesthesia ]
    Time from end of MRI until recovery defined as Aldrete Score = 10


Secondary Outcome Measures :
  1. Demission time [ Time Frame: 1 - 4 hours post anaesthesia ]
    time until demission

  2. PONV [ Time Frame: 24 hours ]
    Postoperative nausea or vomiting

  3. 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

  4. Incidence of emergence delirium [ Time Frame: 1 - 4 hours post anaesthesia ]
  5. Quality of sedation [ Time Frame: during MRI, on the average 45 minutes ]
    Extra Propofol doses and total amount of Propofol required, movement artefacts

  6. respiratory and cardiovascular adverse events [ Time Frame: during sedation, on the average 60 minutes ]


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Ages Eligible for Study:   3 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519154


Locations
Switzerland
University Children's Hospital Zurich
Zurich, Switzerland, 8032
Sponsors and Collaborators
Achim Schmitz
Investigators
Principal Investigator: Achim J Schmitz, MD University Children's Hospital, Zurich

Responsible Party: Achim Schmitz, Principal Investigator, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01519154     History of Changes
Other Study ID Numbers: KEK-ZH Nr. 2011-0190
2011DR3171 ( Other Identifier: Swissmedic Referenznummer )
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Achim Schmitz, University Children's Hospital, Zurich:
deep sedation
propofol
ketamine
child
preschool child
infant
recovery and quality of sedation

Additional relevant MeSH terms:
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action