Sedation MRI – Propofol Versus Propofol-Ketamin in Children
Overview
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 both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow. Hypothesis: 1. reduces recovery time compared to propofol mono sedation 2. combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation 3. combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation
Full Title of Study: “Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: November 2014
Interventions
- Drug: Propofol
- Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
- Drug: Ketamine-Propofol
- Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion
Arms, Groups and Cohorts
- Active Comparator: Propofol
- Propofol 10 mg/h as maintenance infusion
- Experimental: Ketamine-Propofol
- Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion
Clinical Trial Outcome Measures
Primary Measures
- Recovery time
- Time Frame: 1 – 3 hours post anaesthesia
- Time from end of MRI until recovery defined as Aldrete Score = 10
Secondary Measures
- Demission time
- Time Frame: 1 – 4 hours post anaesthesia
- time until demission
- PONV
- Time Frame: 24 hours
- Postoperative nausea or vomiting
- Cerebral perfusion
- Time Frame: first 10 minutes of MRI
- noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI
- Incidence of emergence delirium
- Time Frame: 1 – 4 hours post anaesthesia
- Quality of sedation
- Time Frame: during MRI, on the average 45 minutes
- Extra Propofol doses and total amount of Propofol required, movement artefacts
- respiratory and cardiovascular adverse events
- Time Frame: during sedation, on the average 60 minutes
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 3 Months
Maximum Age: 10 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Achim Schmitz
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Achim Schmitz, Principal Investigator – University Children’s Hospital, Zurich
- Overall Official(s)
- Achim J Schmitz, MD, Principal Investigator, University Children’s Hospital, Zurich
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