In Reply
[摘要] We appreciate the interest for our randomized controlled trial of our esteemed readers. Pupillometry enables a safe reduction of intraoperative opioid consumption in cardiac anesthesia, resulting in hemodynamic stability and less postoperative pain, but without influencing the primary endpoint of extubation time. We refer to the eMethods section (1), and are pleased to discuss this relevant limitation in more detail here as well. Specifically, the study was stopped early based on the study results at an a priori planned 50% interim analysis (n = 64/128 randomized participants, of 200 patients to be screened), which were evaluated very positively at the DAC 2019 and 2020; this early study termination was CONSORT-compliant, with feedback to the local ethics committee due to the ethically justified concerns about withholding these advantages of a drastic opioid reduction from further patients. Thus, randomization and preoperative exclusion resulted in unequal group sizes and distribution (eFigure 1) (1).
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[效力级别] [学科分类] 医学(综合)
[关键词] [时效性]