Study Stopped
Intermediate analysis
Postoperative Sedation After Cardiac Surgery
SEDCAR
2 other identifiers
interventional
19
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 17, 2017
May 1, 2017
2 years
June 26, 2015
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Level of sedation
Richmond Agitation-Sedation Scale measured until extubation
6 hours
Secondary Outcomes (20)
Level of pain during sedation
6 hours
Changes in hemodynamics profile consecutive to a tracheal suctioning
6 hours
Changes in Bispectral Index consecutive to a tracheal suctioning
6 hours
Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning
6 hours
Changes in Behavioral Pain Scale consecutive to a tracheal suctioning
6 hours
- +15 more secondary outcomes
Study Arms (1)
Automated postoperative sedation
EXPERIMENTALPostoperative 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.
Interventions
Eligibility Criteria
You may qualify if:
- consent for participation
- cardiac surgical procedure requiring postoperative sedation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Clinique Ambroise Paré
Neuilly-sur-Seine, Hauts-de-Seine, 92200, France
Related Publications (1)
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.
PMID: 23223772BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2015
First Posted
July 2, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 17, 2017
Record last verified: 2017-05