Sedation MRI - Propofol Versus Propofol-Ketamin in Children | NCT01519154

Studies
Sedation MRI - Propofol Versus Propofol-Ketamin in Children

NCT01519154

Sponsor

Achim Schmitz

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

347Actual

Phase

Phase 3

Conditions

Sedation

Interventions

Propofol
Ketamine-Propofol

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011DR3171	Other Identifier	Swissmedic Referenznummer

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2018Actual

Primary Completion Date

Jun 4, 2024Actual

Completion Date

Jun 4, 2024Actual

First Submitted Date

Jan 17, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2024

Last Update Posted Date

Dec 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

347Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol	Active Comparator	Propofol 10 mg/h as maintenance infusion	Drug: Propofol
Ketamine-Propofol	Experimental	Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion	Drug: Ketamine-Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion	Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery time	Time from end of MRI until recovery defined as Aldrete Score = 10	1 - 3 hours post anaesthesia

Secondary Outcomes

Measure	Description	Time Frame
Demission time	time until demission	1 - 4 hours post anaesthesia
PONV	Postoperative nausea or vomiting	24 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Achim J Schmitz, MD	University Children's Hospital, Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital Zurich		Zurich		8032	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

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