Indiana University School of Medicine, Indiana University, Indianapolis, IN, USA.
Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN, USA.
Br J Anaesth. 2024 Nov;133(5):940-954. doi: 10.1016/j.bja.2024.06.008. Epub 2024 Jul 14.
Intraoperative controlled hypotension improves surgical field visibility by reducing blood loss (efficacy) but poses potential risks linked to organ hypoperfusion (safety). The use of controlled hypotension persists despite increasing evidence of associations between intraoperative inadvertent hypotension and adverse outcomes. Therefore, we tested the hypothesis that the focus and results of intraoperative controlled hypertension research differ across anaesthesia and surgery investigators because of differing priorities.
We systematically reviewed randomised trials comparing controlled hypotension with usual care with trials categorised by investigators' affiliation.
We identified 48 eligible trials, of which 37 were conducted by anaesthesia investigators and 11 by surgery investigators. For the primary outcome, 54% of the anaesthesia-led trials focused on safety, whereas all (100%) surgery-led trials focused on efficacy (P=0.004). Compared with usual care, mean arterial pressure in controlled hypotension was 23% (95% confidence interval [CI] 17-29%) lower in anaesthesia trials and 30% (95% CI 14-37%) lower in surgery trials; estimated blood loss was 44% (95% CI 30-55%) less in anaesthesia trials and 38% (95% CI 30-49%) less in surgery trials. Overall, blood loss was reduced by 43% (95% CI 32-53%), and trial sequential analysis supported an efficacy conclusion. Mean arterial pressure and estimated blood loss reductions were associated (R=0.41, P=0.002). All trials were underpowered for safety outcomes, and none adequately evaluated myocardial or renal injury.
Anaesthesia researchers prioritised safety outcomes, whereas surgery researchers emphasised efficacy in controlled hypotension trials. Controlled hypotension significantly reduces blood loss. In contrast, safety outcomes were poorly studied. Given increasing observational evidence linking inadvertent hypotension to myocardial and renal injury, the safety of controlled hypotension remains to be addressed.
PROSPERO (CRD42023450397).
术中控制性降压通过减少出血量(疗效)来提高手术视野的可见度,但会带来与器官低灌注相关的潜在风险(安全性)。尽管越来越多的证据表明术中意外低血压与不良结局之间存在关联,但控制性降压的应用仍在持续。因此,我们检验了这样一个假设,即由于优先事项不同,麻醉和手术研究人员对术中控制性高血压研究的重点和结果存在差异。
我们系统地综述了比较控制性降压与常规护理的随机试验,并根据研究人员的隶属关系对试验进行了分类。
我们确定了 48 项符合条件的试验,其中 37 项由麻醉研究人员开展,11 项由外科研究人员开展。对于主要结局,54%的麻醉主导试验关注安全性,而所有(100%)外科主导试验都关注疗效(P=0.004)。与常规护理相比,控制性降压组的平均动脉压在麻醉试验中降低了 23%(95%置信区间 17-29%),在外科试验中降低了 30%(95%置信区间 14-37%);估计失血量在麻醉试验中减少了 44%(95%置信区间 30-55%),在外科试验中减少了 38%(95%置信区间 30-49%)。总体而言,失血量减少了 43%(95%置信区间 32-53%),试验序贯分析支持疗效结论。平均动脉压和估计失血量的降低呈相关关系(R=0.41,P=0.002)。所有试验在安全性结局方面均未达到足够的效力,且均未充分评估心肌或肾脏损伤。
麻醉研究人员优先考虑安全性结局,而外科研究人员在控制性降压试验中强调疗效。控制性降压显著减少出血量。相比之下,安全性结局研究不足。鉴于越来越多的观察性证据表明意外低血压与心肌和肾脏损伤有关,控制性降压的安全性仍有待解决。
PROSPERO(CRD42023450397)。