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Sedation MRI - Propofol Versus Propofol-Ketamin in Children

NCT01519154 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2024-12-20

No results posted yet for this study

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

Conditions

  • Sedation

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

Sponsors & Collaborators

  • Achim Schmitz

    lead OTHER

Principal Investigators

  • Achim J Schmitz, MD · University Children's Hospital, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2024-06-04
Completion
2024-06-04

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519154 on ClinicalTrials.gov