Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Achim Schmitz

Status and phase: Completed; Phase 3

Conditions: Sedation

Treatments: Drug: Propofol; Drug: Ketamine-Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01519154

2011DR3171 (Other Identifier)

KEK-ZH Nr. 2011-0190

Details and patient eligibility

About

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

Enrollment: 347 patients

Sex: All

Ages: 3 months to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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347 participants in 2 patient groups

Propofol

Active Comparator group

Description:

Propofol 10 mg/h as maintenance infusion

Treatment:

Drug: Propofol

Ketamine-Propofol

Experimental group

Description:

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

Treatment:

Drug: Ketamine-Propofol