Anesthesia Clinical Trial
— SEPOCAOfficial title:
Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation
Verified date | October 2021 |
Source | CMC Ambroise Paré |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.
Status | Terminated |
Enrollment | 7 |
Est. completion date | March 30, 2019 |
Est. primary completion date | March 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CMC Ambroise Paré | Neuilly-sur-Seine | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
CMC Ambroise Paré |
France,
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. 20 — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequate sedation | Percentage of time with BIS between 55 and 75 (BIS(55-75)) | 6 hours | |
Secondary | Period of too deep sedation | Percentage of time with BIS values less than 55 | 6 hours | |
Secondary | Period of too light sedation | Percentage of time with BIS values greater than 75 | 6 hours | |
Secondary | Incidence of Burst Suppression (bsr) during sedation | Presence of Burst Suppression defined by a rate > 10% for at least one minute | 6 hours | |
Secondary | Level of sedation | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) | 6 hours | |
Secondary | 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) |
6 hours | |
Secondary | Medical interventions | Number and causes of transient or permanent interruptions in automated administration | 6 hours | |
Secondary | Hemodynamic status during the sedation period | Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm) | 6 hours | |
Secondary | Sedation time | Duration of sedation | 6 hours | |
Secondary | Delay before awakening | Delay between the cessation of infusion of propofol and remifentanil and extubation. | 6 hours | |
Secondary | Dose of hypnotic drug | Total amount of propofol during sedation period | 6 hours | |
Secondary | Dose of analgesic drug | Total amount of remifentanil during sedation period | 6 hours | |
Secondary | Level of consciousness after extubation | Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert & calm) | 9 hours | |
Secondary | 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) |
9 hours | |
Secondary | Awareness during the sedation period | Awareness standardized questionnaire | 48 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04279054 -
Decreased Neuraxial Morphine After Cesarean Delivery
|
Early Phase 1 | |
Active, not recruiting |
NCT04580030 -
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
|
||
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Recruiting |
NCT04099693 -
A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
|
||
Terminated |
NCT02481999 -
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
|
||
Completed |
NCT04235894 -
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
|
||
Recruiting |
NCT05525104 -
The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).
|
N/A | |
Recruiting |
NCT05024084 -
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth
|
Phase 4 | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03277872 -
NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
|
N/A | |
Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
Terminated |
NCT02529696 -
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Terminated |
NCT03704285 -
Development of pk/pd Model of Propofol in Patients With Severe Burns
|
||
Recruiting |
NCT05259787 -
EP Intravenous Anesthesia in Hysteroscopy
|
Phase 4 | |
Completed |
NCT02894996 -
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?
|
N/A | |
Completed |
NCT05386082 -
Anesthesia Core Quality Metrics Consensus Delphi Study
|
||
Terminated |
NCT03567928 -
Laryngeal Mask in Upper Gastrointestinal Procedures
|
N/A | |
Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
Completed |
NCT04163848 -
CARbon Impact of aNesthesic Gas
|