Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial

Julia Y. Nicklas , Alina Bergholz , Francesco Däke , Hanh H.D. Pham , Marie-Christin Rabe , Hanna Schlichting , Sophia Skrovanek , Moritz Flick , Karim Kouz , Marlene Fischer , Cynthia Olotu , Jakob R. Izbicki , Oliver Mann , Margit Fisch , Barbara Schmalfeldt , Karl-Heinz Frosch , Thomas Renné , Linda Krause , Christian Zöllner , Bernd Saugel
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Abstract

Background

It remains unknown whether there is a causal relationship between intraoperative hypotension and postoperative neurocognitive disorders. We tested the hypothesis that personalised—compared to routine—intraoperative blood pressure management reduces the incidence of postoperative neurocognitive disorders in patients having major noncardiac surgery.

Methods

In this single-centre trial, 328 elective major noncardiac surgery patients were randomly allocated to receive personalised blood pressure management (i.e. maintaining intraoperative mean arterial pressure [MAP] above preoperative baseline MAP from automated 24-h blood pressure monitoring) or routine blood pressure management (i.e. maintaining MAP above 65 mm Hg). The primary outcome was the incidence of neurocognitive disorders (composite of delayed neurocognitive recovery and delirium) between postoperative days 3 and 7.

Results

The primary outcome, neurocognitive disorders, occurred in 18 of 147 patients (12%) assigned to personalised and 21 of 148 patients (14%) assigned to routine blood pressure management (odds ratio [OR]=0.84, 95% confidence interval [CI]: 0.40–1.75, P=0.622). Delayed neurocognitive recovery occurred in 17 of 146 patients (12%) assigned to personalised and 17 of 145 patients (12%) assigned to routine blood pressure management (OR=0.99, 95% CI: 0.45–2.17, P=0.983). Delirium occurred in 2 of 157 patients (1%) assigned to personalised and 4 of 158 patients (3%) assigned to routine blood pressure management (OR=0.50, 95% CI: 0.04–3.53, P=0.684).

Conclusions

Personalised intraoperative blood pressure management maintaining preoperative baseline MAP neither reduced the incidence of the composite primary outcome neurocognitive disorders between postoperative days 3 and 7 nor the incidences of the components of the composite primary outcome—delayed neurocognitive recovery and delirium—compared to routine blood pressure management in patients having major noncardiac surgery.

Clinical trial registration

ClinicalTrials.gov (NCT03442907).

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非心脏大手术期间的个性化血压管理与术后神经认知障碍:随机试验
背景目前仍不清楚术中低血压与术后神经认知障碍之间是否存在因果关系。在这项单中心试验中,328 名择期接受重大非心脏手术的患者被随机分配接受个性化血压管理(即术中平均动脉压 [MAP] 保持在 24 小时自动血压监测的术前基线 MAP 以上)或常规血压管理(即 MAP 保持在 65 mm Hg 以上)。主要结果是术后第 3 天和第 7 天之间神经认知障碍(神经认知延迟恢复和谵妄的复合结果)的发生率。结果147 名患者中有 18 名(12%)被分配到个性化血压管理方案,148 名患者中有 21 名(14%)被分配到常规血压管理方案(几率比 [OR]= 0.84,95% 置信区间 [CI]:0.40-1.75,P=0.622)。在 146 名被分配到个性化血压管理的患者中,有 17 人(12%)出现神经认知功能延迟恢复;在 145 名被分配到常规血压管理的患者中,有 17 人(12%)出现神经认知功能延迟恢复(OR=0.99,95% 置信区间[CI]:0.45-2.17,P=0.983)。在157名接受个性化血压管理的患者中,有2人(1%)出现谵妄;在158名接受常规血压管理的患者中,有4人(3%)出现谵妄(OR=0.50,95% CI:0.04-3.53,P=0.684)。结论与常规血压管理相比,个性化术中血压管理维持术前基线MAP既不会降低非心脏大手术患者术后第3天和第7天的综合主要结果神经认知障碍的发生率,也不会降低综合主要结果的组成部分--神经认知恢复延迟和谵妄的发生率。
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来源期刊
BJA open
BJA open Anesthesiology and Pain Medicine
CiteScore
0.60
自引率
0.00%
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0
审稿时长
83 days
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