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Sedation MRI - Propofol Versus Propofol-Ketamin in Children

NCT ID: NCT01519154

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2024-06-04

Brief Summary

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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

Detailed Description

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Conditions

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Sedation

Keywords

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deep sedation propofol ketamine child preschool child infant recovery and quality of sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Propofol

Propofol 10 mg/h as maintenance infusion

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion

Ketamine-Propofol

Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion

Group Type EXPERIMENTAL

Ketamine-Propofol

Intervention Type DRUG

Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion

Interventions

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Propofol

Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion

Intervention Type DRUG

Ketamine-Propofol

Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Achim Schmitz

OTHER

Sponsor Role lead

Responsible Party

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Achim Schmitz

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Achim J Schmitz, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

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University Children's Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2011DR3171

Identifier Type: OTHER

Identifier Source: secondary_id

KEK-ZH Nr. 2011-0190

Identifier Type: -

Identifier Source: org_study_id