Surgery, CardiacSEDCARNCT02488486
Postoperative Sedation After Cardiac Surgery
A study testing Automated postoperative sedation, propofol and remifentanil in people with Surgery, Cardiac and Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Cardiac, Anesthesia
- What is being tested?
- Automated postoperative sedation, propofol and remifentanil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to May 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consent for participation
- cardiac surgical procedure requiring postoperative sedation
Who cannot join
- pregnant women,
- neurological or muscular disorder
- high risk of revision surgery
- patients having required a redo operation if the postoperative period of sedation was less than 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Sedation After Cardiac Surgery: Pilot Study
This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.
- Conditions
- Surgery, Cardiac, Anesthesia
- Being tested
- Automated postoperative sedation, propofol, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated postoperative sedationDevice
Also called algorithm is the property of Medsteer SAS
propofolDrug
remifentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| Automated postoperative sedation | Experimental | Postoperative sedation is provided automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 40 and 60. Receives: Device: Automated postoperative sedation; Drug: propofol; Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of sedation
Richmond Agitation-Sedation Scale measured until extubation
Measured: 6 hours
Secondary outcomes (20)
Level of pain during sedation
Behavioral Pain Scale measured until extubation
Measured: 6 hours
Changes in hemodynamics profile consecutive to a tracheal suctioning
Measured: 6 hours
Changes in Bispectral Index consecutive to a tracheal suctioning
Measured: 6 hours
Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning
Measured: 6 hours
Changes in Behavioral Pain Scale consecutive to a tracheal suctioning
Measured: 6 hours
Changes in concentration of propofol consecutive to a tracheal suctioning
Measured: 6 hours
Changes in concentration of remifentanil consecutive to a tracheal suctioning
Measured: 6 hours
Delay before awakening
Delay between the cessation of infusion of propofol and remifentanil and extubation.
Measured: 6 hours
Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil
Measured: 6 hours
Calculation of indices of performance of the closed-loop system
Measured: 6 hours
Periods of electrical silence
Number and duration of electroencephalographic periods of silence
Measured: 6 hours
Total amounts of propofol observed during sedation period
Measured: 6 hours
Total amounts of remifentanil observed during sedation period
Measured: 6 hours
Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values
Measured: 6 hours
Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.
Measured: 6 hours
Hemodynamic status during the sedation period
Evolution of hemodynamic parameters (composite)
Measured: 6 hours
Hemodynamic status during the sedation period
Number of medical interventions
Measured: 6 hours
Level of consciousness after extubation
Richmond Agitation-Sedation Scale assessed every hour for three hours after extubation
Measured: 6 hours
Pain after extubation
Simple numerical scale from 0 (no pain) to 10 (worst possible) assessed every hour for three hours after extubation
Measured: 6 hours
Awareness standardized questionnaire
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Intermediate analysis
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 Surgery, CardiacStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488486
- Sponsor's protocol ID
- 2014/24
- Other IDs
- 2014-A00949-38
- Acronym
- SEDCAR
- Status last verified
- May 2017
- First submitted
- 26 Jun 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.
PubMed 23223772
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sedation After Cardiac Surgery: Pilot Study
- ClinicalTrials.gov ID
- NCT02488486
- Acronym / sponsor ID
- SEDCAR / 2014/24
- Conditions
- Surgery, Cardiac, Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intermediate analysis
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Jul 2015 (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 pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated postoperative sedation | Experimental | Device: Automated postoperative sedation, Drug: propofol, Drug: remifentanilPostoperative sedation is provided automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 40 and 60. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- consent for participation
- cardiac surgical procedure requiring postoperative sedation
Key exclusion criteria (4 listed)
- pregnant women,
- neurological or muscular disorder
- high risk of revision surgery
- patients having required a redo operation if the postoperative period of sedation was less than 2 hours
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 |
|---|---|---|
| Automated postoperative sedationAlso: algorithm is the property of Medsteer SAS | Device | Automated postoperative sedation |
| propofol | Drug | Automated postoperative sedation |
| remifentanil | Drug | Automated postoperative sedation |
Primary outcome
Level of sedation
Time frame: 6 hours
Richmond Agitation-Sedation Scale measured until extubation
20 secondary outcomes
Level of pain during sedation
Time frame: 6 hours
Changes in hemodynamics profile consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in Bispectral Index consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in Behavioral Pain Scale consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in concentration of propofol consecutive to a tracheal suctioning
Time frame: 6 hours
Changes in concentration of remifentanil consecutive to a tracheal suctioning
Time frame: 6 hours
Delay before awakening
Time frame: 6 hours
Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil
Time frame: 6 hours
Calculation of indices of performance of the closed-loop system
Time frame: 6 hours
Periods of electrical silence
Time frame: 6 hours
Total amounts of propofol observed during sedation period
Time frame: 6 hours
Total amounts of remifentanil observed during sedation period
Time frame: 6 hours
Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values
Time frame: 6 hours
Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.
Time frame: 6 hours
Hemodynamic status during the sedation period
Time frame: 6 hours
Hemodynamic status during the sedation period
Time frame: 6 hours
Level of consciousness after extubation
Time frame: 6 hours
Pain after extubation
Time frame: 6 hours
Awareness standardized questionnaire
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Intermediate analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Background: PubMed 23223772Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated postoperative sedation, propofol and remifentanil in people with Surgery, Cardiac and Anesthesia, run by Hopital Foch 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 2 inclusion and 4 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 17 May 2017. 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.
Are results available for this study?
The study was stopped early (reason given: Intermediate analysis). 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?
Level of sedation (time frame: 6 hours). 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 NCT02488486, 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 17 May 2017.