Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
NCT ID: NCT03476213
Last Updated: 2024-05-10
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2018-03-16
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group TCI
induction and anesthesia will be held by using target-controll infusion
Group TCI
Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.
Group TIVA
induction and anesthesia will be held by manual dosing of propofol and sufentanil
Group TIVA
Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.
Interventions
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Group TCI
Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.
Group TIVA
Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.
Eligibility Criteria
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Inclusion Criteria
* ASA Physical Status Classification System I - III
* planed surgery for brain tumor to 5 hours
* postoperative awakening
Exclusion Criteria
* abuse of stimulating drugs, grass, alcohol dependence
* BMI over 40 in females and over 35 in men
* propofol alergie
* awake operations
* postoperative arteficial ventilation
18 Years
ALL
No
Sponsors
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University Hospital Hradec Kralove
OTHER
Responsible Party
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Dostalova Vlasta, MD, PhD
Principal Investigator
Principal Investigators
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Pavel Dostal, MD, Ph.D.
Role: STUDY_DIRECTOR
University Hospital Hradec Kralove
Locations
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University Hospital Hradec Kralove
Hradec Králové, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201506S
Identifier Type: -
Identifier Source: org_study_id
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