Postoperative Sedation After Cardiac Surgery: Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Automated postoperative sedation
- Conditions
- Surgery, Cardiac
- Sponsor
- Hopital Foch
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Level of sedation
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •consent for participation
- •cardiac surgical procedure requiring postoperative sedation
Exclusion Criteria
- •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
Arms & Interventions
Automated postoperative sedation
Postoperative 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.
Intervention: Automated postoperative sedation
Automated postoperative sedation
Postoperative 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.
Intervention: propofol
Automated postoperative sedation
Postoperative 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.
Intervention: remifentanil
Outcomes
Primary Outcomes
Level of sedation
Time Frame: 6 hours
Richmond Agitation-Sedation Scale measured until extubation
Secondary Outcomes
- Total amounts of propofol observed during sedation period(6 hours)
- Changes in Richmond Agitation-Sedation Scale consecutive to a tracheal suctioning(6 hours)
- Changes in concentration of propofol consecutive to a tracheal suctioning(6 hours)
- 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 Behavioral Pain Scale consecutive to a tracheal suctioning(6 hours)
- Changes in concentration of remifentanil consecutive to a tracheal suctioning(6 hours)
- Calculation of indices of performance of the closed-loop system(6 hours)
- Pain after extubation(6 hours)
- Delay before awakening(6 hours)
- Number of temporary or definitive interruptions of the automated administration of propofol and remifentanil(6 hours)
- Total amounts of remifentanil observed during sedation period(6 hours)
- Changes in calculated plasma concentrations of propofol including minimum concentrations and maximum values(6 hours)
- Changes in calculated plasma concentrations of remifentanil including minimum concentrations and maximum values.(6 hours)
- Hemodynamic status during the sedation period(6 hours)
- Level of consciousness after extubation(6 hours)
- Periods of electrical silence(6 hours)
- Awareness standardized questionnaire(48 hours)