Factors Influencing Anesthetic Drug Requirement (PosoAnes)
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ClinicalTrials.gov Identifier: NCT00896714 |
Recruitment Status
:
Recruiting
First Posted
: May 12, 2009
Last Update Posted
: March 28, 2017
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Sponsor:
Hopital Foch
Information provided by (Responsible Party):
Hopital Foch
Tracking Information | |||||
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First Submitted Date ICMJE | May 8, 2009 | ||||
First Posted Date ICMJE | May 12, 2009 | ||||
Last Update Posted Date | March 28, 2017 | ||||
Study Start Date ICMJE | May 2009 | ||||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ] | ||||
Original Primary Outcome Measures ICMJE |
The dose of propofol required to maintain BIS between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ] | ||||
Change History | Complete list of historical versions of study NCT00896714 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Factors Influencing Anesthetic Drug Requirement | ||||
Official Title ICMJE | Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study) | ||||
Brief Summary | The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Not Applicable | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anesthesia, General | ||||
Intervention ICMJE | Device: Closed loop anesthesia
Propofol and Remifentanil are administered automatically using a closed-loop system |
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Study Arms | Experimental: Closed loop anesthesia
Intervention: Device: Closed loop anesthesia |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
5000 | ||||
Original Estimated Enrollment ICMJE |
4500 | ||||
Estimated Study Completion Date | June 2017 | ||||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00896714 | ||||
Other Study ID Numbers ICMJE | 2008/44 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Hopital Foch | ||||
Study Sponsor ICMJE | Hopital Foch | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hopital Foch | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |