Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia
NCT ID: NCT03465423
Last Updated: 2019-02-08
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
62 participants
OBSERVATIONAL
2018-03-20
2018-12-04
Brief Summary
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On arrival in the operating room, standard monitoring devices, including electrocardiogram, pulse oximetry, noninvasive blood pressure cuff, and bispectral index (BIS) will be applied to the patients. Propofol with the modified Marsh pharmacokinetic parameters using a keo of 1.2/min will be administered through TCI pump (OrchestraBase Primea, Fresenius Vial, France). The initial target Ce of propofol will be chosen as 3.0 mg/mL (0.5 mg/mL of incremental size) based on an earlier study.
The sedation of patients will be assessed with BIS score and the modified observer's assessment of awareness and sedation (OAA/S). LOC was defined as an OAA/S lower than 2 (loss of response to spoken command to eye opening and loss of response to mild prodding or shaking). The primary end point of this study is the Ce of propofol when the BIS score is 40. The secondary end point of this study is the Ce of propofol at LOC.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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patients with nonfunctioning pituitary tumor
patients with nonfunctioning pituitary tumor undergoing transsphenoidal pituitary surgery under total intravenous anesthesia
Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)
The patients of two cohort group will undergo general anesthesia in the same way and therefore there is no intervention in this study.
patients with pituitary somatotroph tumor
patients with pituitary somatotroph tumor undergoing transsphenoidal pituitary surgery under total intravenous anesthesia
Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)
The patients of two cohort group will undergo general anesthesia in the same way and therefore there is no intervention in this study.
Interventions
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Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)
The patients of two cohort group will undergo general anesthesia in the same way and therefore there is no intervention in this study.
Eligibility Criteria
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Inclusion Criteria
* American society of anesthesiologists classification 1 or 2
Exclusion Criteria
* serum Creatinine \> 1.0mg/dl
* myocardial infarction or cerebral stroke in 1 yrs
* fever \> 38C
* dementia, cognitive disorder, confused mental status
* pregnant patients
* allergic to propofol
* illiteracy or foreigners
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Associate Professor Department of Anesthesiology and Pain Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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4-2017-1241
Identifier Type: -
Identifier Source: org_study_id
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