NCT01519154
Completed
Phase 3
Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
Achim Schmitz1 site in 1 country347 target enrollmentFebruary 9, 2018
Overview
- Phase
- Phase 3
- Intervention
- Propofol
- Conditions
- Sedation
- Sponsor
- Achim Schmitz
- Enrollment
- 347
- Locations
- 1
- Primary Endpoint
- Recovery time
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Achim Schmitz
Principal Investigator
University Children's Hospital, Zurich
Eligibility Criteria
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
Arms & Interventions
Propofol
Propofol 10 mg/h as maintenance infusion
Intervention: Propofol
Ketamine-Propofol
Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion
Intervention: Ketamine-Propofol
Outcomes
Primary Outcomes
Recovery time
Time Frame: 1 - 3 hours post anaesthesia
Time from end of MRI until recovery defined as Aldrete Score = 10
Secondary Outcomes
- Incidence of emergence delirium(1 - 4 hours post anaesthesia)
- Quality of sedation(during MRI, on the average 45 minutes)
- respiratory and cardiovascular adverse events(during sedation, on the average 60 minutes)
- Demission time(1 - 4 hours post anaesthesia)
- PONV(24 hours)
- Cerebral perfusion(first 10 minutes of MRI)
Study Sites (1)
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