Sedation
Conditions
Keywords
deep sedation, propofol, ketamine, child, preschool child, infant, recovery and quality of sedation
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 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
Interventions
DRUGPropofol
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
Sponsors
Achim Schmitz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | 1 - 3 hours post anaesthesia | Time from end of MRI until recovery defined as Aldrete Score = 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of sedation | during MRI, on the average 45 minutes | Extra Propofol doses and total amount of Propofol required, movement artefacts |
| respiratory and cardiovascular adverse events | during sedation, on the average 60 minutes | — |
| PONV | 24 hours | Postoperative nausea or vomiting |
| Incidence of emergence delirium | 1 - 4 hours post anaesthesia | — |
| Demission time | 1 - 4 hours post anaesthesia | time until demission |
| Cerebral perfusion | first 10 minutes of MRI | noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI |
Countries
Switzerland
Outcome results
None listed