AnesthesiaPhase 4PropofolRemiNCT01592162
Comparison of Different Propofol Formulations With or Without Remifentanil
A Phase 4 study testing Propofol (Astra-Zeneca), NaCl 0.9%, propofol 1% (Astra-Zeneca) and remifentanil and Propofol (Astra-Zeneca) and remifentanil in people with Anesthesia, run by Hopital Foch at 2 sites in France.
Trial summary
The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol (Astra-Zeneca), NaCl 0.9%, propofol 1% (Astra-Zeneca) and remifentanil and Propofol (Astra-Zeneca) and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 2 sitesFrance
- Study dates
- May 2013to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for an intravenous induction of anesthesia with propofol
Who cannot join
- Age under 18
- Pregnancy or breastfeeding
- Allergy to propofol, soya or peanuts,
- Allergy to remifentanil,
- History of central neurological disorder or brain injury,
- Patients receiving psychotropic drugs,
- Patient with a pacemaker
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Besançon
Besançon, 25034
Hopital Foch
Suresnes, Île-de-France Region, 92151
About this study
Official title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
- Conditions
- Anesthesia
- Being tested
- Propofol (Astra-Zeneca), NaCl 0.9%, propofol 1% (Astra-Zeneca) and remifentanil, Propofol (Astra-Zeneca) and remifentanil, Propofol (B-Braun) and NaCl 0.9%, Propofol (B-Braun) and remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol (Astra-Zeneca), NaCl 0.9%Drug
propofol administered by a closed-loop system and saline
propofol 1% (Astra-Zeneca) and remifentanilDrug
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
propofol 1% (Astra-Zeneca) and remifentanilDrug
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
Propofol (Astra-Zeneca), NaCl 0.9%Drug
propofol administered by a closed-loop system and saline
Propofol (Astra-Zeneca) and remifentanilDrug
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Propofol (Astra-Zeneca) and remifentanilDrug
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
Propofol (B-Braun) and NaCl 0.9%Drug
propofol administered by a closed-loop system and saline
Propofol (B-Braun) and remifentanilDrug
propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
Propofol (B-Braun) and remifentanilDrug
propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
| Study group | Role | What they receive |
|---|---|---|
| propofol 1% (Astra-Zeneca) - remi 0 | Active comparator | propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml Receives: Drug: Propofol (Astra-Zeneca), NaCl 0.9% |
| propofol 1% (Astra-Zeneca) - remi 2 | Active comparator | propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml Receives: Drug: propofol 1% (Astra-Zeneca) and remifentanil |
| propofol 1% (Astra-Zeneca) - remi 4 | Active comparator | propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml Receives: Drug: propofol 1% (Astra-Zeneca) and remifentanil |
| propofol 1% (Fresenius) - remi 0 | Active comparator | propofol 1% (Fresenius) plus remifentanil 0 ng/ml Receives: Drug: Propofol (Astra-Zeneca), NaCl 0.9% |
| propofol 1% (Fresenius) - remi 2 | Active comparator | propofol 1% (Fresenius) plus remifentanil 2 ng/ml Receives: Drug: Propofol (Astra-Zeneca) and remifentanil |
| propofol 1% (Fresenius) - remi 4 | Active comparator | propofol 1% (Fresenius) plus remifentanil 4 ng/ml Receives: Drug: Propofol (Astra-Zeneca) and remifentanil |
| propofol 1% (B-Braun) - remi 0 | Active comparator | propofol 1% (B-Braun) plus remifentanil 0 ng/ml Receives: Drug: Propofol (B-Braun) and NaCl 0.9% |
| propofol 1% (B-Braun) - remi 2 | Active comparator | propofol 1% (B-Braun) plus remifentanil 2 ng/ml Receives: Drug: Propofol (B-Braun) and remifentanil |
| propofol 1% (B-Braun) - remi 4 | Active comparator | propofol 1% (B-Braun) plus remifentanil 4 ng/ml Receives: Drug: Propofol (B-Braun) and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
Measured: one hour after anesthesia
Secondary outcomes (6)
calculated concentrations of propofol at the end of the anesthetic induction
Measured: one hour after anesthesia
pain at injection
Measured: one hour after anesthesia
heart rate modifications induced by anesthetic induction
Measured: one hour after anesthesia
patient's satisfaction
Measured: one day after anesthesia
arterial pressure modifications induced by anesthetic induction
Measured: one hour after anesthesia
Disappearance of the eyelash reflex
Measured: One hour after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2013
- Primary completionNov 2014
- Study completionNov 2014
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592162
- Sponsor's protocol ID
- 2011/34
- Other IDs
- 2011-002644-27
- Acronym
- PropofolRemi
- Status last verified
- Nov 2016
- First submitted
- 17 Apr 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
- ClinicalTrials.gov ID
- NCT01592162
- Acronym / sponsor ID
- PropofolRemi / 2011/34
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 May 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.
The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| propofol 1% (Astra-Zeneca) - remi 0 | Active comparator | Drug: Propofol (Astra-Zeneca), NaCl 0.9%propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml |
| propofol 1% (Astra-Zeneca) - remi 2 | Active comparator | Drug: propofol 1% (Astra-Zeneca) and remifentanilpropofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml |
| propofol 1% (Astra-Zeneca) - remi 4 | Active comparator | Drug: propofol 1% (Astra-Zeneca) and remifentanilpropofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml |
| propofol 1% (Fresenius) - remi 0 | Active comparator | Drug: Propofol (Astra-Zeneca), NaCl 0.9%propofol 1% (Fresenius) plus remifentanil 0 ng/ml |
| propofol 1% (Fresenius) - remi 2 | Active comparator | Drug: Propofol (Astra-Zeneca) and remifentanilpropofol 1% (Fresenius) plus remifentanil 2 ng/ml |
| propofol 1% (Fresenius) - remi 4 | Active comparator | Drug: Propofol (Astra-Zeneca) and remifentanilpropofol 1% (Fresenius) plus remifentanil 4 ng/ml |
| propofol 1% (B-Braun) - remi 0 | Active comparator | Drug: Propofol (B-Braun) and NaCl 0.9%propofol 1% (B-Braun) plus remifentanil 0 ng/ml |
| propofol 1% (B-Braun) - remi 2 | Active comparator | Drug: Propofol (B-Braun) and remifentanilpropofol 1% (B-Braun) plus remifentanil 2 ng/ml |
| propofol 1% (B-Braun) - remi 4 | Active comparator | Drug: Propofol (B-Braun) and remifentanilpropofol 1% (B-Braun) plus remifentanil 4 ng/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for an intravenous induction of anesthesia with propofol
Key exclusion criteria (7 listed)
- Age under 18
- Pregnancy or breastfeeding
- Allergy to propofol, soya or peanuts,
- Allergy to remifentanil,
- History of central neurological disorder or brain injury,
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 |
|---|---|---|
| Propofol (Astra-Zeneca), NaCl 0.9%propofol administered by a closed-loop system and saline | Drug | propofol 1% (Astra-Zeneca) - remi 0 |
| propofol 1% (Astra-Zeneca) and remifentanilpropofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion) | Drug | propofol 1% (Astra-Zeneca) - remi 2 |
| propofol 1% (Astra-Zeneca) and remifentanilpropofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion) | Drug | propofol 1% (Astra-Zeneca) - remi 4 |
| Propofol (Astra-Zeneca), NaCl 0.9%propofol administered by a closed-loop system and saline | Drug | propofol 1% (Fresenius) - remi 0 |
| Propofol (Astra-Zeneca) and remifentanilpropofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion) | Drug | propofol 1% (Fresenius) - remi 2 |
| Propofol (Astra-Zeneca) and remifentanilpropofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion) | Drug | propofol 1% (Fresenius) - remi 4 |
| Propofol (B-Braun) and NaCl 0.9%propofol administered by a closed-loop system and saline | Drug | propofol 1% (B-Braun) - remi 0 |
| Propofol (B-Braun) and remifentanilpropofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion) | Drug | propofol 1% (B-Braun) - remi 2 |
| Propofol (B-Braun) and remifentanilpropofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion) | Drug | propofol 1% (B-Braun) - remi 4 |
Primary outcome
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
Time frame: one hour after anesthesia
6 secondary outcomes
calculated concentrations of propofol at the end of the anesthetic induction
Time frame: one hour after anesthesia
pain at injection
Time frame: one hour after anesthesia
heart rate modifications induced by anesthetic induction
Time frame: one hour after anesthesia
patient's satisfaction
Time frame: one day after anesthesia
arterial pressure modifications induced by anesthetic induction
Time frame: one hour after anesthesia
Disappearance of the eyelash reflex
Time frame: One hour after anesthesia
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 3 Nov 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
Hopital Foch
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 (Astra-Zeneca), NaCl 0.9%, propofol 1% (Astra-Zeneca) and remifentanil and Propofol (Astra-Zeneca) 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 1 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 3 Nov 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 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?
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds) (time frame: one hour after 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 3 Nov 2016.