Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Study Overview
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Brief Summary
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Children < 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow. Hypothesis: reduces recovery time compared to propofol mono sedation combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation

Official Title
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Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)

Conditions
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Sedation

Intervention / Treatment
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* Drug: Propofol
* Drug: Ketamine-Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRT in deep sedation outpatient > 3 months to <= 10 years Exclusion Criteria: tracheal intubation required contraindication of ketamine or propofol additional painful procedure requiring analgesics

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Propofol 10 mg/h as maintenance infusion | Drug: Propofol<br>* Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion<br>|
| Experimental: Ketamine-Propofol<br>Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion | Drug: Ketamine-Propofol<br>* Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time | Time from end of MRI until recovery defined as Aldrete Score = 10 | 1 - 3 hours post anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demission time | time until demission | 1 - 4 hours post anaesthesia | 
| PONV | Postoperative nausea or vomiting | 24 hours | 
| Cerebral perfusion | noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI | first 10 minutes of MRI | 
| Incidence of emergence delirium |  | 1 - 4 hours post anaesthesia | 
| Quality of sedation | Extra Propofol doses and total amount of Propofol required, movement artefacts | during MRI, on the average 45 minutes | 
| respiratory and cardiovascular adverse events |  | during sedation, on the average 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, deep sedation, propofol, ketamine, preschool child, infant, recovery and quality of sedation