AnesthesiaSEPOCANCT03517735
Automated Postoperative Sedation After Cardiac Surgery
A study testing EasyTiva (algorithm is the property of Medsteer SAS), Propofol and Remifentanil in people with Anesthesia and Sedation, run by CMC Ambroise Paré at 1 site in France.
Trial summary
This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Sedation, Surgery, Cardiac
- What is being tested?
- EasyTiva (algorithm is the property of Medsteer SAS), Propofol and Remifentanil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2018to 30 Mar 2019
- 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
- Cardiac surgical procedure requiring postoperative sedation
- Low operative risk : EuroSCORE 2 ≤ 5%
- Consent for participation
- Affiliation to the social security system
Who cannot join
- Pregnant or breastfeeding women
- Neurological or muscular disorder
- Pacemaker
- Hypersensitivity to propofol or remifentanil
- Communication difficulties or neuropsychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation
This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.
Read the detailed description
Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation.
Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor.
Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity.
This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.
- Conditions
- Anesthesia, Sedation, Surgery, Cardiac
- Being tested
- EasyTiva (algorithm is the property of Medsteer SAS), Propofol, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyTiva (algorithm is the property of Medsteer SAS)Device
Propofol and Remifentanil are administered 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 55 and 75.
PropofolDrug
The dosage is modified automatically by the device or according to the new medical prescription.
RemifentanilDrug
The dosage is modified automatically by the device or according to the new medical prescription.
| Study group | Role | What they receive |
|---|---|---|
| Automated postoperative sedation | Experimental | Automated administration of Propofol and Remifentanil. Receives: Device: EasyTiva (algorithm is the property of Medsteer SAS); Drug: Propofol; Drug: Remifentanil |
| Manual postoperative sedation | Active comparator | Manual administration of Propofol and Remifentanil. Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate sedation
Percentage of time with BIS between 55 and 75 (BIS(55-75))
Measured: 6 hours
Secondary outcomes (14)
Period of too deep sedation
Percentage of time with BIS values less than 55
Measured: 6 hours
Period of too light sedation
Percentage of time with BIS values greater than 75
Measured: 6 hours
Incidence of Burst Suppression (bsr) during sedation
Presence of Burst Suppression defined by a rate > 10% for at least one minute
Measured: 6 hours
Level of sedation
Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert \& calm)
Measured: 6 hours
Level of pain during sedation
Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed :
- Numeric Scale for Facial expression : from 1 (relaxed) to 4 (grimacing)
- Numeric Scale for Upper limb movements : from 1 (no movement) to 4 (permanently retracted)
- Numeric Scale for Compliance with mechanical ventilation : from 1 (tolerating movement) to 4 (unable to control ventilation)
Measured: 6 hours
Medical interventions
Number and causes of transient or permanent interruptions in automated administration
Measured: 6 hours
Hemodynamic status during the sedation period
Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm)
Measured: 6 hours
Sedation time
Duration of sedation
Measured: 6 hours
Delay before awakening
Delay between the cessation of infusion of propofol and remifentanil and extubation.
Measured: 6 hours
Dose of hypnotic drug
Total amount of propofol during sedation period
Measured: 6 hours
Dose of analgesic drug
Total amount of remifentanil during sedation period
Measured: 6 hours
Level of consciousness after extubation
Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert \& calm)
Measured: 9 hours
Level of pain after extubation
Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed :
- Numeric Scale for Facial expression : from 1 (relaxed) to 4 (grimacing)
- Numeric Scale for Upper limb movements : from 1 (no movement) to 4 (permanently retracted)
- Numeric Scale for Compliance with mechanical ventilation : from 1 (tolerating movement) to 4 (unable to control ventilation)
Measured: 9 hours
Awareness during the sedation period
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 posted7 May 2018
- Study start17 Dec 2018
- Primary completion28 Mar 2019
- Study completion30 Mar 2019
Why it stopped: Modification of the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Chazot, MD, Study chair, Hôpital FOCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517735
- Sponsor's protocol ID
- 2017/03
- Acronym
- SEPOCA
- Status last verified
- Oct 2021
- First submitted
- 19 Apr 2018
- Last updated
- 5 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
PubMed 21233500Le 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 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation
- ClinicalTrials.gov ID
- NCT03517735
- Acronym / sponsor ID
- SEPOCA / 2017/03
- Conditions
- Anesthesia, Sedation, Surgery, Cardiac
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Modification of the device
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 May 2018 (actual)
- 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 study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.
Detailed description
Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation.
Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor.
Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity.
This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated postoperative sedation | Experimental | Device: EasyTiva (algorithm is the property of Medsteer SAS), Drug: Propofol, Drug: RemifentanilAutomated administration of Propofol and Remifentanil. |
| Manual postoperative sedation | Active comparator | Drug: Propofol, Drug: RemifentanilManual administration of Propofol and Remifentanil. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cardiac surgical procedure requiring postoperative sedation
- Low operative risk : EuroSCORE 2 ≤ 5%
- Consent for participation
- Affiliation to the social security system
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Neurological or muscular disorder
- Pacemaker
- Hypersensitivity to propofol or remifentanil
- Communication difficulties or neuropsychiatric disorder
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 |
|---|---|---|
| EasyTiva (algorithm is the property of Medsteer SAS)Propofol and Remifentanil are administered 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 55 and 75. | Device | Automated postoperative sedation |
| PropofolThe dosage is modified automatically by the device or according to the new medical prescription. | Drug | Automated postoperative sedation, Manual postoperative sedation |
| RemifentanilThe dosage is modified automatically by the device or according to the new medical prescription. | Drug | Automated postoperative sedation, Manual postoperative sedation |
Primary outcome
Adequate sedation
Time frame: 6 hours
Percentage of time with BIS between 55 and 75 (BIS(55-75))
14 secondary outcomes
Period of too deep sedation
Time frame: 6 hours
Period of too light sedation
Time frame: 6 hours
Incidence of Burst Suppression (bsr) during sedation
Time frame: 6 hours
Level of sedation
Time frame: 6 hours
Level of pain during sedation
Time frame: 6 hours
Medical interventions
Time frame: 6 hours
Hemodynamic status during the sedation period
Time frame: 6 hours
Sedation time
Time frame: 6 hours
Delay before awakening
Time frame: 6 hours
Dose of hypnotic drug
Time frame: 6 hours
Dose of analgesic drug
Time frame: 6 hours
Level of consciousness after extubation
Time frame: 9 hours
Level of pain after extubation
Time frame: 9 hours
Awareness during the sedation period
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Modification of the device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Results publication: PubMed 21233500Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
- Results publication: 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.
- 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.
Thierry Chazot, MD study chair
Hôpital FOCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EasyTiva (algorithm is the property of Medsteer SAS), Propofol and Remifentanil in people with Anesthesia and Sedation, run by CMC Ambroise Paré 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 4 inclusion and 5 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 5 Nov 2021. 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: Modification of the device). 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?
Adequate 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 NCT03517735, which also lists 2 linked publications.
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 5 Nov 2021.