CancerPhase 2CONCERTNCT02889718
Anesthesia Feasibility Study With the CONCERT-CL® Station
A Phase 2 study testing CONCERT-CL® station and Surgery in people with Cancer and Surgery, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CONCERT-CL® station and Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2015to 15 Dec 2016
- Phase
- Phase 2
- 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
- men and women aged 18 years old and over
- Surgery of any type programmed for longer than 1 hour
- Anesthesia combining three agents: hypnotic, morphine, curare
Who cannot join
- minor patient
- pregnant and lactating women
- Known or suspected hypersensitivity to propofol,
- known or suspected hypersensitivity to remifentanil and other fentanyl derivatives,
- known or suspected hypersensitivity to rocuronium and atracurium, preventing the use of the two products.
- peanut allergy, soy, Egg
Show all 18Show fewer
- neurological disease history with known modification of the electroencephalogram
- severe eye disease, ocular implant, standing diabetes with diabetic retinopathy
- gravis
- pacemakers patient
- surgery whose position is not suitable for a monitoring on the ulnar nave
- general anesthesia associated with regional anesthesia
- Simultaneous use of shortwave therapy or microwave
- Simultaneous use of high frequency surgical apparatus
- 15 patients under supervision or unable to consent
- patient undergoing psychiatric care
- patient in a health or social institution
- emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.
This is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.
Read more
Secondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.
The study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.
- Being tested
- CONCERT-CL® station, Surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONCERT-CL® stationDevice
During cancer surgery (surgery > 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents:
- Port B = open loop: Analgesic
- Port A = closed loop: Hypnotic
- Port C = closed loop: Curare
SurgeryOther
Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| anaesthesia with CONCERT-CL® station | Experimental | During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station Receives: Device: CONCERT-CL® station; Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station
The evaluation will measure the level of hypnosis during surgery.
=> The performance of the closed loop of the CONCERT-CL® station will be evaluated by studying its overall score (GS).
Measured: From start of anesthesia until the release of the patient from recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start16 Feb 2015
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAVOUNGOU Philippe, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889718
- Sponsor's protocol ID
- ICO-N-2014-07
- Acronym
- CONCERT
- Status last verified
- May 2019
- First submitted
- 25 Aug 2016
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer
- ClinicalTrials.gov ID
- NCT02889718
- Acronym / sponsor ID
- CONCERT / ICO-N-2014-07
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 7 Sep 2016 (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.
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.
This is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.
Secondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.
The study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anaesthesia with CONCERT-CL® station | Experimental | Device: CONCERT-CL® station, Other: SurgeryDuring the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women aged 18 years old and over
- Surgery of any type programmed for longer than 1 hour
- Anesthesia combining three agents: hypnotic, morphine, curare
Key exclusion criteria (18 listed)
- minor patient
- pregnant and lactating women
- Known or suspected hypersensitivity to propofol,
- known or suspected hypersensitivity to remifentanil and other fentanyl derivatives,
- known or suspected hypersensitivity to rocuronium and atracurium, preventing the use of the two products.
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 |
|---|---|---|
| CONCERT-CL® stationDuring cancer surgery (surgery > 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents: * Port B = open loop: Analgesic * Port A = closed loop: Hypnotic * Port C = closed loop: Curare | Device | anaesthesia with CONCERT-CL® station |
| SurgeryRegardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour. | Other | anaesthesia with CONCERT-CL® station |
Primary outcome
During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station
Time frame: From start of anesthesia until the release of the patient from recovery room
The evaluation will measure the level of hypnosis during surgery. => The performance of the closed loop of the CONCERT-CL® station will be evaluated by studying its overall score (GS).
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 16 May 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.
MAVOUNGOU Philippe, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CONCERT-CL® station and Surgery in people with Cancer and Surgery, run by Institut Cancerologie de l'Ouest at 1 site 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 18 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 16 May 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station (time frame: From start of anesthesia until the release of the patient from recovery room). 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 16 May 2019.