Sedation MRI - Propofol Versus Propofol-Ketamin in Children

This study is currently recruiting participants.

Verified June 2013 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: June 13, 2013

Last verified: June 2013

History of Changes

Purpose

Children < 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are

propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h
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:

reduces recovery time compared to propofol mono sedation
combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation
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:

Drug Information available for: Ketamine hydrochloride Propofol Ketamine

U.S. FDA Resources

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

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:	June 13, 2013
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 June 17, 2013

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