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Completed

NCT Number: NCT01519154

Sedation MRI - Propofol Versus Propofol-Ketamin in Children

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

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Key information

Conditions

Sedation

Age range

3 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Ketamine-Propofol

Drug

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

Primary outcomes

  1. Recovery time

    Time frame: 1 - 3 hours post anaesthesia

    Time from end of MRI until recovery defined as Aldrete Score = 10

Secondary outcomes

  1. Demission time

    Time frame: 1 - 4 hours post anaesthesia

    time until demission

  2. PONV

    Time frame: 24 hours

    Postoperative nausea or vomiting

  3. Cerebral perfusion

    Time frame: first 10 minutes of MRI

    noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI

  4. Incidence of emergence delirium

    Time frame: 1 - 4 hours post anaesthesia

  5. Quality of sedation

    Time frame: during MRI, on the average 45 minutes

    Extra Propofol doses and total amount of Propofol required, movement artefacts

  6. respiratory and cardiovascular adverse events

    Time frame: during sedation, on the average 60 minutes

Sponsors and collaborators

Lead sponsor

Achim Schmitz

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2012
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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