General AnesthesiaNCT00949507
Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia
An observational study of General Anesthesia and Children, run by Niels Anker Pedersen at 1 site in Denmark.
Trial summary
Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- General Anesthesia, Children, MRI
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia
Who may be able to join
- children aged 1 to 10 yrs.
- ASA 1-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital, Dept. of Anesthesia
Glostrup Municipality, Copenhagen, DK-2600
About this study
Official title: Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.
Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.
- Conditions
- General Anesthesia, Children, MRI, Sevoflurane, Propofol/Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
postanaesthetic recovery and behavioral score
Measured: 0-24 hours hours postoperatively
Secondary outcomes (1)
Time span of the recovery process
Measured: 0-3 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niels Anker Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niels Anker Pedersen, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949507
- Sponsor's protocol ID
- 2008-209
- Other IDs
- EudraCT 2008-002690-12, 2008-41-2609, 2612-3762, H-A-2008-060
- Status last verified
- May 2013
- First submitted
- 29 Jul 2009
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.
- ClinicalTrials.gov ID
- NCT00949507
- Acronym / sponsor ID
- 2008-209
- Conditions
- General Anesthesia, Children, MRI, Sevoflurane, Propofol/Remifentanil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Niels Anker PedersenUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia
Key inclusion criteria (2 listed)
- children aged 1 to 10 yrs.
- ASA 1-2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postanaesthetic recovery and behavioral score
Time frame: 0-24 hours hours postoperatively
1 secondary outcome
Time span of the recovery process
Time frame: 0-3 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Children, run by Niels Anker Pedersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postanaesthetic recovery and behavioral score (time frame: 0-24 hours hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.