Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation
Overview
- Phase
- Not Applicable
- Intervention
- Remifentanil
- Conditions
- Anesthesia
- Sponsor
- CMC Ambroise Paré
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Adequate sedation
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
Manual postoperative sedation
Manual administration of Propofol and Remifentanil.
Intervention: Remifentanil
Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
Intervention: EasyTiva (algorithm is the property of Medsteer SAS)
Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
Intervention: Propofol
Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
Intervention: Remifentanil
Manual postoperative sedation
Manual administration of Propofol and Remifentanil.
Intervention: Propofol
Outcomes
Primary Outcomes
Adequate sedation
Time Frame: 6 hours
Percentage of time with BIS between 55 and 75 (BIS(55-75))
Secondary Outcomes
- Level of sedation(6 hours)
- Dose of hypnotic drug(6 hours)
- Awareness during the sedation period(48 hours)
- Period of too light sedation(6 hours)
- Level of pain after extubation(9 hours)
- Period of too deep sedation(6 hours)
- Level of pain during sedation(6 hours)
- Incidence of Burst Suppression (bsr) during sedation(6 hours)
- Medical interventions(6 hours)
- Sedation time(6 hours)
- Delay before awakening(6 hours)
- Dose of analgesic drug(6 hours)
- Level of consciousness after extubation(9 hours)
- Hemodynamic status during the sedation period(6 hours)