Clinical trial NCT03517735: Automated Postoperative Sedation After Cardiac Surgery
Official title: Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Sedation
Surgery, Cardiac
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Cardiac surgical procedure requiring postoperative sedation
* Low operative risk : EuroSCORE 2 ≤ 5%
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Pregnant or breastfeeding women
* Neurological or muscular disorder
* Pacemaker
* Hypersensitivity to propofol or remifentanil
* Communication difficulties or neuropsychiatric disorder

Primary outcomes:
measure: Adequate sedation
timeFrame: 6 hours
Secondary outcomes:
measure: Period of too deep sedation
timeFrame: 6 hours
measure: Period of too light sedation
timeFrame: 6 hours
measure: Incidence of Burst Suppression (bsr) during sedation
timeFrame: 6 hours
measure: Level of sedation
timeFrame: 6 hours
measure: Level of pain during sedation
timeFrame: 6 hours
measure: Medical interventions
timeFrame: 6 hours
measure: Hemodynamic status during the sedation period
timeFrame: 6 hours
measure: Sedation time
timeFrame: 6 hours
measure: Delay before awakening
timeFrame: 6 hours
measure: Dose of hypnotic drug
timeFrame: 6 hours
measure: Dose of analgesic drug
timeFrame: 6 hours
measure: Level of consciousness after extubation
timeFrame: 9 hours
measure: Level of pain after extubation
timeFrame: 9 hours
measure: Awareness during the sedation period
timeFrame: 48 hours
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile-de-France
Study officials:
affiliation: Hôpital FOCH
name: Thierry Chazot, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.