Hypotension is a common side effect of general anesthesia induction, and its incidence in non-cardiac surgeries is reportedly 9–60%. Remimazolam has been approved for general anesthesia or procedural sedation. Its metabolites have a 410-fold lower affinity in humans. Remimazolam besylate is a novel short-acting drug that is rapidly metabolized by liver esterases. This does not alter our adherence to PLOS ONE policies on sharing data and materials. Takahisa Goto received honoraria from Mundipharma K.K. Kenichi Masui was a consultant/advisor for Mundipharma K.K., Tokyo, Japan, and has been awarded a research grant for another study and has received payment for delivering domestic lectures from Mundipharma K.K. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ĭata Availability: All relevant data from this study will be made available upon study completion.įunding: The authors received no specific funding for this work.Ĭompeting interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Received: Accepted: SeptemPublished: September 30, 2022Ĭopyright: © 2022 Yokose et al. PLoS ONE 17(9):Įditor: Walid Kamal Abdelbasset, Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, SAUDI ARABIA (2022) Hypotension after general anesthesia induction using remimazolam in geriatric patients: Protocol for a double-blind randomized controlled trial. Logistic regression analysis will be performed to explore the factors associated with the incidence of hypotension after anesthesia induction.Ĭitation: Yokose M, Takaki R, Mihara T, Saigusa Y, Yamamoto N, Masui K, et al. Secondary outcomes will be analyzed using the Fisher’s exact test, Student’s t test, and Mann–Whitney U test, as appropriate.
Subgroup analysis of the primary outcome will be performed based on the Charlson comorbidity index, clinical frailty scale, hypertension in the ward, and age. The incidence of hypotension in the two groups will be compared using the Mantel-Haenszel χ2 test.
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The primary outcome will be analyzed using the full analysis set. We define hypotension as mean blood pressure <65 mmHg. The primary outcome is the incidence of hypotension after general anesthesia induction, occurring between the start of drug administration and 3 min after intubation.
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This single-center, double-blind, randomized, two-arm parallel group, standard treatment-controlled, interventional clinical trial will include 90 patients aged ≥80 years undergoing elective surgery under general anesthesia who will be randomized to receive remimazolam or propofol for induction.
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