Sedation MRI - Propofol Versus Propofol-Ketamin in Children
Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
2 other identifiers
interventional
347
1 country
1
Brief Summary
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
- 3.reduces recovery time compared to propofol mono sedation
- 4.combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation
- 5.combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2018
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedStudy Start
First participant enrolled
February 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2024
CompletedDecember 20, 2024
December 1, 2024
6.3 years
January 17, 2012
December 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recovery time
Time from end of MRI until recovery defined as Aldrete Score = 10
1 - 3 hours post anaesthesia
Secondary Outcomes (6)
Demission time
1 - 4 hours post anaesthesia
PONV
24 hours
Cerebral perfusion
first 10 minutes of MRI
Incidence of emergence delirium
1 - 4 hours post anaesthesia
Quality of sedation
during MRI, on the average 45 minutes
- +1 more secondary outcomes
Study Arms (2)
Propofol
ACTIVE COMPARATORPropofol 10 mg/h as maintenance infusion
Ketamine-Propofol
EXPERIMENTALAdditional Ketamine at induction, Propofol 5 mg/h as maintenance infusion
Interventions
Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion
Eligibility Criteria
You may qualify if:
- MRT in deep sedation
- outpatient
- \> 3 months to \<= 10 years
You may not qualify if:
- tracheal intubation required
- contraindication of ketamine or propofol
- additional painful procedure requiring analgesics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Achim Schmitzlead
Study Sites (1)
University Children's Hospital Zurich
Zurich, 8032, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Achim J Schmitz, MD
University Children's Hospital, Zurich
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 17, 2012
First Posted
January 26, 2012
Study Start
February 9, 2018
Primary Completion
June 4, 2024
Study Completion
June 4, 2024
Last Updated
December 20, 2024
Record last verified: 2024-12