General AnesthesiaPhase 4PropofolsNCT01041872
Comparison of Different Propofol Formulations
A Phase 4 study testing Propofol Astrazeneca plain, Propofol Astrazeneca plus lidocaine and Propofol-lipuro B. Braun plain in people with General Anesthesia, run by Hopital Foch at 3 sites in France.
Trial summary
The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine 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
- General Anesthesia
- What is being tested?
- Propofol Astrazeneca plain, Propofol Astrazeneca plus lidocaine and Propofol-lipuro B. Braun plain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2009to Jul 2011
- 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 lidocaine,
- History of central neurological disorder or brain injury,
- Patients receiving psychotropic drugs,
- Patient with a pacemaker.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Saint Augustin
Bordeaux, 33000
Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré
Garches, 92380
Hôpital Foch
Suresnes, 92151
About this study
Official title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine
The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
- Conditions
- General Anesthesia
- Being tested
- Propofol Astrazeneca plain, Propofol Astrazeneca plus lidocaine, Propofol-lipuro B. Braun plain, Propofol-lipuro B. Braun plus lidocaine, Propofol Fresenius plain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol Astrazeneca plainDrug
Also called Propofol Astrazeneca
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Propofol Astrazeneca plus lidocaineDrug
Also called Propofol Astrazeneca, Lidocaine
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Propofol-lipuro B. Braun plainDrug
Also called Propofol-lipuro B. Braun
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Propofol-lipuro B. Braun plus lidocaineDrug
Also called Propofol-lipuro B. Braun, lidocaine
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
Propofol Fresenius plainDrug
Also called Propofol Fresenius
Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.
Propofol Fresenius plus lidocaineDrug
Also called Propofol Fresenius, lidocaine
Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Astrazeneca | Active comparator | Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. Receives: Drug: Propofol Astrazeneca plain |
| Propofol Astrazeneca plus lidocaine | Experimental | Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. Receives: Drug: Propofol Astrazeneca plus lidocaine |
| Propofol-lipuro B. Braun plain | Experimental | Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. Receives: Drug: Propofol-lipuro B. Braun plain |
| Propofol-lipuro B. Braun plus lidocaine | Experimental | Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. Receives: Drug: Propofol-lipuro B. Braun plus lidocaine |
| Propofol Fresenius plain | Experimental | Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. Receives: Drug: Propofol Fresenius plain |
| Propofol Fresenius plus lidocaine | Experimental | Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. Receives: Drug: Propofol Fresenius plus lidocaine |
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 of 50)
Measured: end of anesthetic induction
Secondary outcomes (7)
calculated concentrations of propofol at the end of the anesthetic induction
Measured: end of the anesthetic induction
measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)
Measured: 3 months after the end of patient's recruitment
pain at injection
Measured: during the PACU (post-anaesthesia care unit) stay
heart rate and arterial pressure modifications induced by anesthetic induction
Measured: end of anesthetic induction
patients satisfaction
Measured: during the PACU stay
necessary dose of propofol to obtain loss of consciousness
Measured: end of anesthetic induction
calculated concentrations of propofol at loss of consciousness
Measured: end of anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan LeGuen, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041872
- Sponsor's protocol ID
- 2009/22
- Acronym
- Propofols
- Status last verified
- Sep 2016
- First submitted
- 31 Dec 2009
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
PubMed 16571963
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 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 Lidocaine
- ClinicalTrials.gov ID
- NCT01041872
- Acronym / sponsor ID
- Propofols / 2009/22
- Conditions
- General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Jan 2010 (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 lidocaine)on anesthetic induction. Propofol plain or with lidocaine 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Propofol Astrazeneca | Active comparator | Drug: Propofol Astrazeneca plainPropofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. |
| Propofol Astrazeneca plus lidocaine | Experimental | Drug: Propofol Astrazeneca plus lidocainePropofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. |
| Propofol-lipuro B. Braun plain | Experimental | Drug: Propofol-lipuro B. Braun plainPropofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. |
| Propofol-lipuro B. Braun plus lidocaine | Experimental | Drug: Propofol-lipuro B. Braun plus lidocainePropofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. |
| Propofol Fresenius plain | Experimental | Drug: Propofol Fresenius plainPropofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. |
| Propofol Fresenius plus lidocaine | Experimental | Drug: Propofol Fresenius plus lidocainePropofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. |
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 lidocaine,
- 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 Astrazeneca plainAlso: Propofol AstrazenecaPropofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. | Drug | Propofol Astrazeneca |
| Propofol Astrazeneca plus lidocaineAlso: Propofol Astrazeneca, LidocainePropofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. | Drug | Propofol Astrazeneca plus lidocaine |
| Propofol-lipuro B. Braun plainAlso: Propofol-lipuro B. BraunPropofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. | Drug | Propofol-lipuro B. Braun plain |
| Propofol-lipuro B. Braun plus lidocaineAlso: Propofol-lipuro B. Braun, lidocainePropofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. | Drug | Propofol-lipuro B. Braun plus lidocaine |
| Propofol Fresenius plainAlso: Propofol FreseniusPropofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline. | Drug | Propofol Fresenius plain |
| Propofol Fresenius plus lidocaineAlso: Propofol Fresenius, lidocainePropofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine. | Drug | Propofol Fresenius plus lidocaine |
Primary outcome
necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)
Time frame: end of anesthetic induction
7 secondary outcomes
calculated concentrations of propofol at the end of the anesthetic induction
Time frame: end of the anesthetic induction
measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)
Time frame: 3 months after the end of patient's recruitment
pain at injection
Time frame: during the PACU (post-anaesthesia care unit) stay
heart rate and arterial pressure modifications induced by anesthetic induction
Time frame: end of anesthetic induction
patients satisfaction
Time frame: during the PACU stay
necessary dose of propofol to obtain loss of consciousness
Time frame: end of anesthetic induction
calculated concentrations of propofol at loss of consciousness
Time frame: end of anesthetic induction
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 26 Sep 2016.
- Background: PubMed 16571963Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
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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.
Morgan LeGuen, MD principal investigator
Hôpital Foch
3 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 Astrazeneca plain, Propofol Astrazeneca plus lidocaine and Propofol-lipuro B. Braun plain in people with General Anesthesia, run by Hopital Foch at 3 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 26 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 3 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 of 50) (time frame: end of anesthetic induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041872, which also lists 1 linked publication.
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 26 Sep 2016.