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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01020643 |
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Date of registration:
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23/11/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia
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Scientific title:
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Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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203 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01020643 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Thomas Hemmerling, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MUHC - MGH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients undergoing hip or knee replacement under spinal anesthesia
Exclusion Criteria:
- contraindication to spinal anesthesia
- allergies to any study drug
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Conscious Sedation
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Intervention(s)
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Drug: controlled administration of propofol
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Primary Outcome(s)
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Controller performance
[Time Frame: 1 year]
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Secondary Outcome(s)
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fluid management
[Time Frame: end of surgery]
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Secondary ID(s)
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09-168-GEN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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