Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niels Anker Pedersen, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:
NCT00949507
First received: July 29, 2009
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.


Condition Phase
General Anesthesia
Children
MRI
Sevoflurane
Propofol/Remifentanil
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • postanaesthetic recovery and behavioral score [ Time Frame: 0-24 hours hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time span of the recovery process [ Time Frame: 0-3 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
anaesthesia using propofol
the children are anaesthetized using intravenous anaesthesia with propofol and remifentanil; a binasal catheter is used for administration of oxygen during the anaesthesia
anaesthesia using sevoflurane
the patients are anaesthetized using sevoflurane 1 MAC; a laryngeal mask is used

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia

Criteria

Inclusion Criteria:

  • children aged 1 to 10 yrs.
  • ASA 1-2

Exclusion Criteria:

  • Allergy to soya (propofol)
  • Allergy to Pentobarbital
  • Allergy to Remifentanil
  • Allergy to Sevoflurane
  • Children undergoing blood tests or further examinations in conjunction with the MRI
  • Children with unexplained fever
  • Children which are evaluated not to be able to keep a open airway
  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: NCT00949507

Locations
Denmark
Glostrup University Hospital, Dept. of Anesthesia
Glostrup, Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Niels Anker Pedersen
  More Information

No publications provided

Responsible Party: Niels Anker Pedersen, MD, Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier: NCT00949507     History of Changes
Other Study ID Numbers: 2008-209, EudraCT 2008-002690-12, 2008-41-2609, 2612-3762, H-A-2008-060
Study First Received: July 29, 2009
Last Updated: May 24, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014