BMJ open · 2025
Comparison of propofol, etomidate and remimazolam on postinduction hypotension in older adults undergoing non-cardiac surgery: protocol for a randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Jin Xiao-Fei, Shen Chen-Yi, Dou Wei, Liu Hong, Ji Fu-Hai, Peng Ke
Аннотация
INTRODUCTION: Post-induction hypotension (PIH) is a critical concern in elderly surgical patients and is associated with adverse postoperative outcomes. This trial aims to compare the effects of propofol, etomidate and remimazolam on the incidence of PIH in older adults undergoing non-cardiac surgery.
METHODS AND ANALYSIS: In this single-centre, triple-arm, randomised controlled trial, 210 patients aged ≥80 years with American Society of Anaesthesiologists physical status I-III undergoing elective non-cardiac surgery will be recruited. All patients will receive general anaesthesia with endotracheal intubation. Patients will be randomised (1:1:1) to receive propofol, remimazolam or etomidate for anaesthesia induction (n=70 per group). The primary outcome is the incidence of PIH (mean arterial pressure (MAP) <65 mm Hg for 1 min) from induction initiation to surgical skin incision. Secondary outcomes include time to successful induction, time to tracheal intubation, MAP reduction >30% from baseline, vasopressor requirements, bradycardia, injection pain, myoclonus, postoperative delirium, and cardiac, cerebral and renal complications during hospitalisation.
ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024-380). The results will be peer-reviewed for publication in a scientific journal.
TRIAL REGISTRATION NUMBER: ChiCTR2400090800.
METHODS AND ANALYSIS: In this single-centre, triple-arm, randomised controlled trial, 210 patients aged ≥80 years with American Society of Anaesthesiologists physical status I-III undergoing elective non-cardiac surgery will be recruited. All patients will receive general anaesthesia with endotracheal intubation. Patients will be randomised (1:1:1) to receive propofol, remimazolam or etomidate for anaesthesia induction (n=70 per group). The primary outcome is the incidence of PIH (mean arterial pressure (MAP) <65 mm Hg for 1 min) from induction initiation to surgical skin incision. Secondary outcomes include time to successful induction, time to tracheal intubation, MAP reduction >30% from baseline, vasopressor requirements, bradycardia, injection pain, myoclonus, postoperative delirium, and cardiac, cerebral and renal complications during hospitalisation.
ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024-380). The results will be peer-reviewed for publication in a scientific journal.
TRIAL REGISTRATION NUMBER: ChiCTR2400090800.