SedationPhase 3NCT01519154
Sedation MRI - Propofol Versus Propofol-Ketamin in Children
A Phase 3 study testing Propofol and Ketamine-Propofol in people with Sedation, run by Achim Schmitz at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 3 months to 10 years
- Conditions the study is for
- Sedation
- What is being tested?
- Propofol and Ketamine-Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Feb 2018to 4 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- MRT in deep sedation
- outpatient
- > 3 months to <= 10 years
Who cannot join
- tracheal intubation required
- contraindication of ketamine or propofol
- additional painful procedure requiring analgesics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
Ketamine-PropofolDrug
Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol 10 mg/h as maintenance infusion Receives: Drug: Propofol |
| Ketamine-Propofol | Experimental | Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion Receives: Drug: Ketamine-Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Time from end of MRI until recovery defined as Aldrete Score = 10
Measured: 1 - 3 hours post anaesthesia
Secondary outcomes (6)
Demission time
time until demission
Measured: 1 - 4 hours post anaesthesia
PONV
Postoperative nausea or vomiting
Measured: 24 hours
Cerebral perfusion
noninvasive measurement of cerebral perfusion by means of MRI only in patients scheduled for cerebral MRI
Measured: first 10 minutes of MRI
Incidence of emergence delirium
Measured: 1 - 4 hours post anaesthesia
Quality of sedation
Extra Propofol doses and total amount of Propofol required, movement artefacts
Measured: during MRI, on the average 45 minutes
respiratory and cardiovascular adverse events
Measured: during sedation, on the average 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study start9 Feb 2018
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achim Schmitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Achim Schmitz, University Children's Hospital, Zurich
- Investigators
- Achim J Schmitz, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519154
- Sponsor's protocol ID
- KEK-ZH Nr. 2011-0190
- Other IDs
- 2011DR3171
- Status last verified
- Dec 2024
- First submitted
- 17 Jan 2012
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
- ClinicalTrials.gov ID
- NCT01519154
- Acronym / sponsor ID
- KEK-ZH Nr. 2011-0190
- Conditions
- Sedation
- Keywords
- deep sedation, propofol, ketamine, child, preschool child, infant, recovery and quality of sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Achim SchmitzUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPropofol 10 mg/h as maintenance infusion |
| Ketamine-Propofol | Experimental | Drug: Ketamine-PropofolAdditional Ketamine at induction, Propofol 5 mg/h as maintenance infusion |
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- MRT in deep sedation
- outpatient
- > 3 months to <= 10 years
Key exclusion criteria (3 listed)
- tracheal intubation required
- contraindication of ketamine or propofol
- additional painful procedure requiring analgesics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolOnly Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion | Drug | Propofol |
| Ketamine-PropofolPropofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion | Drug | Ketamine-Propofol |
Primary outcome
Recovery time
Time frame: 1 - 3 hours post anaesthesia
Time from end of MRI until recovery defined as Aldrete Score = 10
6 secondary outcomes
Demission time
Time frame: 1 - 4 hours post anaesthesia
PONV
Time frame: 24 hours
Cerebral perfusion
Time frame: first 10 minutes of MRI
Incidence of emergence delirium
Time frame: 1 - 4 hours post anaesthesia
Quality of sedation
Time frame: during MRI, on the average 45 minutes
respiratory and cardiovascular adverse events
Time frame: during sedation, on the average 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achim J Schmitz, MD principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol and Ketamine-Propofol in people with Sedation, run by Achim Schmitz at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: 1 - 3 hours post anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.