Sedation MRI - Propofol Versus Propofol-Ketamin in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
Achim Schmitz, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01519154
First received: January 17, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Sedation
Drug: Propofol
Drug: Ketamine-Propofol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • Recovery time [ Time Frame: 1 - 3 hours post anaesthesia ] [ Designated as safety issue: No ]
    Time from end of MRI until recovery defined as Aldrete Score = 10


Secondary Outcome Measures:
  • Demission time [ Time Frame: 1 - 4 hours post anaesthesia ] [ Designated as safety issue: No ]
    time until demission

  • PONV [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Postoperative nausea or vomiting

  • Cerebral perfusion [ Time Frame: first 10 minutes of MRI ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Quality of sedation [ Time Frame: during MRI, on the average 45 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Months to 10 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519154

Contacts
Contact: Achim J Schmitz, MD 0041 44 266 7104 achim.schmitz@kispi.uzh.ch

Locations
Switzerland
University Children's Hospital Zurich Recruiting
Zurich, Switzerland, 8032
Contact: Schmitz       achim.schmitz@kispi.uzh.ch   
Principal Investigator: Achim J Schmitz, MD         
Sub-Investigator: Ruth O'Gorman, PhD         
Sub-Investigator: Makki Malek, PhD         
Sub-Investigator: Ianina Scheer, MD         
Sub-Investigator: Christian J Kellenberger, MD         
Sub-Investigator: Dubravka Deanovic, MD         
Sub-Investigator: Georg Henze, MD         
Sub-Investigator: Melanie Fruehauf, MD         
Sub-Investigator: Martin Hölzle, MD         
Sub-Investigator: Markus Weiss, Prof, MD         
Sponsors and Collaborators
Achim Schmitz
Investigators
Principal Investigator: Achim J Schmitz, MD University Children's Hospital, Zurich
  More Information

No publications provided

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
Study First Received: January 17, 2012
Last Updated: February 13, 2014
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on July 23, 2014