NCT00949507

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

2.6 years

First QC Date

July 29, 2009

Last Update Submit

May 24, 2013

Conditions

General AnesthesiaChildrenMRISevofluranePropofol/Remifentanil

Outcome Measures

Primary Outcomes (1)

  • postanaesthetic recovery and behavioral score

    0-24 hours hours postoperatively

Secondary Outcomes (1)

  • Time span of the recovery process

    0-3 hours postoperatively

Study Arms (2)

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 Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup University Hospital, Dept. of Anesthesia

Glostrup Municipality, Copenhagen, DK-2600, Denmark

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

October 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations

DK(1)