Sedation MRI - Propofol Versus Propofol-Ketamin in Children

November 26, 2014 updated by: Achim Schmitz

Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: 1 - 3 hours post anaesthesia
Time from end of MRI until recovery defined as Aldrete Score = 10
1 - 3 hours post anaesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demission time
Time Frame: 1 - 4 hours post anaesthesia
time until demission
1 - 4 hours post anaesthesia
PONV
Time Frame: 24 hours
Postoperative nausea or vomiting
24 hours
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
first 10 minutes of MRI
Incidence of emergence delirium
Time Frame: 1 - 4 hours post anaesthesia
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
during MRI, on the average 45 minutes
respiratory and cardiovascular adverse events
Time Frame: during sedation, on the average 60 minutes
during sedation, on the average 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Achim Schmitz

Investigators

  • Principal Investigator: Achim J Schmitz, MD, University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH Nr. 2011-0190
  • 2011DR3171 (Other Identifier: Swissmedic Referenznummer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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