Calculated and Graphically Produced Depth of Anesthesia
NCT ID: NCT03807271
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2019-01-14
2019-11-13
Brief Summary
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Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay.
New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Smart Pilot(R) View
Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia.
Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.
Standard
Anesthesia provided by standard procedure.
No interventions assigned to this group
Interventions
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Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.
Eligibility Criteria
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Inclusion Criteria
* Standard premedication
* General anesthesia, total intravenous anesthesia
Exclusion Criteria
* BMI 35 or higher
* Unable to give consent
18 Years
75 Years
FEMALE
No
Sponsors
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Sykehuset Innlandet HF
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Heidi Vifladt, MD
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
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Anestesiavdeling Lillehammer Sykehus
Lillehammer, Oppland, Norway
Countries
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References
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Strand H, Elshaug AC, Bernersen O, Ballangrud R. Effectiveness of the advisory display SmartPilot(R) view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial. BMC Anesthesiol. 2022 Feb 28;22(1):57. doi: 10.1186/s12871-022-01593-w.
Other Identifiers
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2018/2176
Identifier Type: -
Identifier Source: org_study_id