CompletedPhase 3ketamine

Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Sponsored by Achim Schmitz

NCT ID
NCT01519154
Target Enrollment
347 participants
Start Date
2018-02-09
Est. Completion
2024-06-04

About This Study

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

Conditions Studied

Sedation

Interventions

  • Propofol
  • Ketamine-Propofol

Eligibility

Age:3 Months - 10 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

University Children's Hospital Zurich
Zurich, Switzerland

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source