Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Sedation Clinical Trial

Official title:

Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519154
• Other study ID #: KEK-ZH Nr. 2011-0190
• Secondary ID: 2011DR3171
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2012
• Last updated: November 26, 2014
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 10 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Propofol
Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
• Ketamine-Propofol
Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Achim Schmitz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time	Time from end of MRI until recovery defined as Aldrete Score = 10	1 - 3 hours post anaesthesia	No
Secondary	Demission time	time until demission	1 - 4 hours post anaesthesia	No
Secondary	PONV	Postoperative nausea or vomiting	24 hours	No
Secondary	Cerebral perfusion	noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI	first 10 minutes of MRI	No
Secondary	Incidence of emergence delirium		1 - 4 hours post anaesthesia	No
Secondary	Quality of sedation	Extra Propofol doses and total amount of Propofol required, movement artefacts	during MRI, on the average 45 minutes	No
Secondary	respiratory and cardiovascular adverse events		during sedation, on the average 60 minutes	Yes