AnesthesiaPhase 4LoopPedNCT00778505
Use of Closed-loop Anesthesia in Pediatric Patients
A Phase 4 study testing Propofol and remifentanil in people with Anesthesia, run by Hopital Foch at 2 sites in France.
Trial summary
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol and remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2008to Dec 2012
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- class ASA I, II or III
- general anesthesia scheduled to last more than one hour
- intraoperative hemorrhage planned to be less than 15% of the blood volume
Who cannot join
- Combined general and regional anesthesia,
- Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
- History of a neurological or a psychiatric disorder, or central brain lesion,
- Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to remifentanil or to a derivate of fentanyl,
- Scheduled postoperative ventilation or sedation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia
- Conditions
- Anesthesia
- Being tested
- Propofol, remifentanil
- Keywords
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
closed-loop administration using bispectral index as the controller
remifentanilDrug
closed-loop administration using bispectral index as the controller
PropofolDrug
manual administration according bispectral index values
RemifentanilDrug
manual administration according bispectral index values
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | closed-loop administration of propofol and remifentanil using bispectral index as the controller Receives: Drug: Propofol; Drug: remifentanil |
| 2 | Active comparator | manual administration of propofol and remifentanil according to bispectral index values Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time during which the bispectral index is between 40 and 60
Measured: anesthesia
Secondary outcomes (1)
propofol and remifentanil doses
Measured: anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch, Suresnes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778505
- Sponsor's protocol ID
- 2008/21
- Acronym
- LoopPed
- Status last verified
- Sep 2016
- First submitted
- 22 Oct 2008
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion
- ClinicalTrials.gov ID
- NCT00778505
- Acronym / sponsor ID
- LoopPed / 2008/21
- Conditions
- Anesthesia
- Keywords
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Oct 2008 (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.
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Propofol, Drug: remifentanilclosed-loop administration of propofol and remifentanil using bispectral index as the controller |
| 2 | Active comparator | Drug: Propofol, Drug: Remifentanilmanual administration of propofol and remifentanil according to bispectral index values |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- class ASA I, II or III
- general anesthesia scheduled to last more than one hour
- intraoperative hemorrhage planned to be less than 15% of the blood volume
Key exclusion criteria (7 listed)
- Combined general and regional anesthesia,
- Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
- History of a neurological or a psychiatric disorder, or central brain lesion,
- Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
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 |
|---|---|---|
| Propofolclosed-loop administration using bispectral index as the controller | Drug | 1 |
| remifentanilclosed-loop administration using bispectral index as the controller | Drug | 1 |
| Propofolmanual administration according bispectral index values | Drug | 2 |
| Remifentanilmanual administration according bispectral index values | Drug | 2 |
Primary outcome
Percentage of time during which the bispectral index is between 40 and 60
Time frame: anesthesia
1 secondary outcome
propofol and remifentanil doses
Time frame: anesthesia
Results and safety
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Marc Fischler, MD study chair
Hôpital Foch, Suresnes, France
2 sites 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 and remifentanil in people with Anesthesia, run by Hopital Foch at 2 sites in France.
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: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
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?
Percentage of time during which the bispectral index is between 40 and 60 (time frame: anesthesia). 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 23 Sep 2016.