PropofolPhase 4TPEPCNCT03426462
Time to Peak Effect of Propofol in Children
A Phase 4 study testing Propofol in people with Propofol and Child, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation… Read more about this study
- Who is it for?
- Ages 1 year to 13 yearsHealthy volunteers can take part
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Apr 2018to 4 Dec 2018
- Phase
- Phase 4
- 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 1 year to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points:
- parental written consent obtained at least a day prior to begin of the subject's study episode; and
- the child is appropriate for induction and maintenance of anaesthesia with propofol.
Who cannot join
- Any significant subject co-morbidity (ASA III or IV);
- Withdrawal of consent/assent at any point in the study;
- Failure to cannulate a peripheral vein prior to induction after two attempts;
- Any other reason making IV induction with propofol impossible;
- Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O);
- previous enrolment in the study;
- Any anaesthetic problem that would take precedence over completion of the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.
- Being tested
- Propofol
- Keywords
- Pharmacodynamic, Permutation Entropy, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.
| Study group | Role | What they receive |
|---|---|---|
| Age 1-6 years | Experimental | Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes.
The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups. Receives: Drug: Propofol |
| Age 8-13 years | Experimental | Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes.
The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to peak effect of a propofol bolus
This is the time from the start of the propofol bolus administration to the maximal suppression of the electroencephalogram; per subject two boli will be administered
Measured: up to 20 minutes from baseline until peak effect following second bolus administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start23 Apr 2018
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Age groups 1-6 years will be compared with 8-13 years whilst undergoing propofol anesthesia to detect whether there is indeed a difference in the speed of onset of the hypnotic effect of the drug.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil Gavel, Principal investigator, Universitäts-Kinderspital beider Basel (UKBB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426462
- Sponsor's protocol ID
- UKBB-2017/032
- Acronym
- TPEPC
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Peak Effect of Propofol in Children
- ClinicalTrials.gov ID
- NCT03426462
- Acronym / sponsor ID
- TPEPC / UKBB-2017/032
- Keywords
- Pharmacodynamic, Permutation Entropy, EEG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- 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.
In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Age groups 1-6 years will be compared with 8-13 years whilst undergoing propofol anesthesia to detect whether there is indeed a difference in the speed of onset of the hypnotic effect of the drug.
| Arm | Type | Receives |
|---|---|---|
| Age 1-6 years | Experimental | Drug: PropofolInduction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes. The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups. |
| Age 8-13 years | Experimental | Drug: PropofolInduction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes. The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups. |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points:
- parental written consent obtained at least a day prior to begin of the subject's study episode; and
- the child is appropriate for induction and maintenance of anaesthesia with propofol.
Key exclusion criteria (7 listed)
- Any significant subject co-morbidity (ASA III or IV);
- Withdrawal of consent/assent at any point in the study;
- Failure to cannulate a peripheral vein prior to induction after two attempts;
- Any other reason making IV induction with propofol impossible;
- Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O);
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 |
|---|---|---|
| PropofolInduction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram. | Drug | Age 1-6 years, Age 8-13 years |
Primary outcome
Time to peak effect of a propofol bolus
Time frame: up to 20 minutes from baseline until peak effect following second bolus administration
This is the time from the start of the propofol bolus administration to the maximal suppression of the electroencephalogram; per subject two boli will be administered
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 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Gil Gavel principal investigator
Universitäts-Kinderspital beider Basel (UKBB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol in people with Propofol and Child, run by University Hospital, Basel, Switzerland 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 7 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 30 Jan 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to peak effect of a propofol bolus (time frame: up to 20 minutes from baseline until peak effect following second bolus administration). 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 30 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.