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Comparism of two sedation protocols during Magnetic Resonans Imaging in children regarding safety and effectiveness

Comparism of two sedation protocols during Magnetic Resonans Imaging in children regarding safety and effectiveness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012338
Enrollment
64
Registered
2017-10-23
Start date
2017-11-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation for Magnetic Resonance Imaging

Interventions

Group 1: Group "P": 1. Premedication: 0,1mg/kg i.v. midanium (midazolam)
2. Bolus: 1mg/kg propofol i.v. in 1 minute (maximum 2 times), 3. Continuous infusion: 4mg/kg propofol i.v. until the end of MRI scanning. "rescue" medication: Ketamine 1mg/kg i.v. Group 2: Group "D":
2. Bolus: 2 mcg/kg dexmedetomidine i.v. in 10 minute (maximum 2 times), 3. Continuous infusion: 2 mcg/kg dexmedetomidine i.v. until the end of MRI scanning. "rescue" medication: Ketamine 1mg/kg i.v.

Sponsors

CSK UM w Lodzi Os. Pediatryczny
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

Inclusion criteria: Magnetic Resonance Imaging with sedation

Exclusion criteria

Exclusion criteria: 1; lack of written consent of the parents. 2; patient ASA III- or higher. 3; Allergies to the studied medication. 4; Contraindications for general anesthesia.

Design outcomes

Primary

MeasureTime frame
To determine if any of the proposed protocols is safer or more effective than the other. Safety: any anesthesiological intervention needed during the sedation (respiratory or circulatory problems). This parameter will be evaluated by the Anethesiological staff. 0: no intervention 1: intervention needed (how many times, what has been done) Effectiveness: sedation is effective if the patient is not moving during the imaging so the images are sharp. This parameter will be evaluated by the radiological staff. 0: sharp images 1: images can not be evaluated

Secondary

MeasureTime frame
To compare the duration of the protocols from the premeditacion untill the patient leaves the post-anethesia care unit.

Countries

Poland

Contacts

Public ContactViktor Brzózka

CSK UM w Lodzi Os. Pediatryczny

vbrzozka@hotmail.com+48 511158520

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026