- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922467
Influence of Esmolol on a Closed-Loop Anesthesia System
September 22, 2016 updated by: Hopital Foch
Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Suresnes, France, 92151
- Hopital Foch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male patients scheduled for a general anesthesia
Exclusion Criteria:
- age lower than 18 years
- allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,
- any other history of anaphylactic reaction,
- hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
- hypersensibility to esmolol or to an excipient,
- history of central nervous system disease,
- patients receiving a psychotropic treatment or an agonist-antagonist opiate,
- hypovolemic patients,
- patients receiving a cardio-vascular treatment,
- patients with a pacemaker,
- expected bleeding more than 20% of the blood volume,
- simultaneous general and loco-regional anesthesia,
- patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
- patients with a heart rate less than 50/min and/or an arterial hypotension,
- neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
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Same volume as in the esmolol group
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Experimental: Esmolol
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol
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1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
administered doses of propofol and of remifentanil during anesthesia
Time Frame: end of anesthesia
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end of anesthesia
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
delay before recovery
Time Frame: at the end of anesthesia
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at the end of anesthesia
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hemodynamic abnormalities requiring a treatment
Time Frame: end of anesthesia
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end of anesthesia
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postoperative morphine requirement
Time Frame: Third post-anesthetic hour
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Third post-anesthetic hour
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explicit memorisation
Time Frame: Second postoperative day
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Second postoperative day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 2, 2009
First Submitted That Met QC Criteria
June 16, 2009
First Posted (Estimate)
June 17, 2009
Study Record Updates
Last Update Posted (Estimate)
September 23, 2016
Last Update Submitted That Met QC Criteria
September 22, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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