Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Phase 3

Completed

• Conditions: Sedation
• Interventions: Drug: Ketamine-Propofol; Drug: Propofol

• Registration Number: NCT01519154
• Lead Sponsor: Achim Schmitz

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2018-02-09
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine-Propofol	Ketamine-Propofol	Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion
Propofol	Propofol	Propofol 10 mg/h as maintenance infusion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of emergence delirium	1 - 4 hours post anaesthesia
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
Demission time	1 - 4 hours post anaesthesia	time until demission
PONV	24 hours	Postoperative nausea or vomiting
Cerebral perfusion	first 10 minutes of MRI	noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI

Trial Locations

Locations (1)

University Children's Hospital Zurich; 🇨🇭 Zurich, Switzerland