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. 2024 Jul 1:11:100294.
doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep.

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

Julia Y Nicklas  1 , Alina Bergholz  1 , Francesco Däke  1 , Hanh H D Pham  1 , Marie-Christin Rabe  1 , Hanna Schlichting  1 , Sophia Skrovanek  1 , Moritz Flick  1 , Karim Kouz  1   2 , Marlene Fischer  3 , Cynthia Olotu  1 , Jakob R Izbicki  4 , Oliver Mann  4 , Margit Fisch  5 , Barbara Schmalfeldt  6 , Karl-Heinz Frosch  7 , Thomas Renné  8   9   10 , Linda Krause  11 , Christian Zöllner  1 , Bernd Saugel  1   2
Affiliations

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

Julia Y Nicklas et al. BJA Open. .

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).

Keywords: anaesthesia; cardiovascular dynamics; haemodynamic monitoring; individualised; morbidity; mortality; randomised controlled trial.

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Conflict of interest statement

MoF is a consultant for Edwards Lifesciences (Irvine, CA, USA) and has received honoraria for consulting and giving lectures from CNSystems Medizintechnik (Graz, Austria). KK is a consultant for and has received honoraria for giving lectures from Edwards Lifesciences. KK is a consultant for Vygon (Aachen, Germany). MarlF receives research support from Medtronic (Minnesota, MN, USA) and from Pfizer Inc. (New York, NY, USA). BeS is a consultant for and has received institutional restricted research grants and honoraria for giving lectures from Edwards Lifesciences. BeS is a consultant for Philips North America (Cambridge, MA, USA) and has received honoraria for giving lectures from Philips Medizin Systeme Böblingen (Böblingen, Germany). BeS has received institutional restricted research grants and honoraria for giving lectures from Baxter (Deerfield, IL, USA). BeS is a consultant for and has received institutional restricted research grants and honoraria for giving lectures from GE Healthcare (Chicago, IL, USA). BeS has received institutional restricted research grants and honoraria for giving lectures from CNSystems Medizintechnik (Graz, Austria). BeS is a consultant for Maquet Critical Care (Solna, Sweden). BeS has received honoraria for giving lectures from Getinge (Gothenburg, Sweden). BeS is a consultant for and has received institutional restricted research grants and honoraria for giving lectures from Pulsion Medical Systems (Feldkirchen, Germany). BeS is a consultant for and has received institutional restricted research grants and honoraria for giving lectures from Vygon (Aachen, Germany). BeS is a consultant for and has received institutional restricted research grants from Retia Medical (Valhalla, NY, USA). BeS has received honoraria for giving lectures from Masimo (Neuchâtel, Switzerland). BeS is a consultant for Dynocardia (Cambridge, MA, USA). BeS has received institutional restricted research grants from Osypka Medical (Berlin, Germany). BeS was a consultant for and has received institutional restricted research grants from Tensys Medical (San Diego, CA, USA). BeS is an editor of the British Journal of Anaesthesia. JYN, AB, FD, HHDP, MCR, HS, SS, CO, JRI, OM, MargF, BaS, KHF, TR, LK, and CZ declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Patient flow chart. Flow chart illustrating patient screening, enrolment, randomisation, and reasons for exclusion.
Figure 2
Figure 2
Preoperative baseline mean arterial pressure. Histograms showing the frequency of preoperative baseline mean arterial pressure (MAP) in patients assigned to personalised and routine blood pressure management. The dashed vertical line in the histogram showing patients assigned to personalised blood pressure management indicates the predefined maximum intraoperative MAP target of 100 mm Hg. MAP, mean arterial pressure.
Figure 3
Figure 3
Intraoperative blood pressures. Boxplots with overlaying one dimensional scatter plots illustrating (a) areas under a mean arterial pressure (MAP) of 65 mm Hg, (b) areas under the preoperative baseline MAP, and (c) boxplots illustrating MAP every 30 min during surgery in patients assigned to personalised and routine blood pressure management. MAP, mean arterial pressure.
Figure 4
Figure 4
Primary outcome. Forest plots showing the effect of personalised compared to routine blood pressure management on the composite primary outcome and components.
See this image and copyright information in PMC

References

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