Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial

Ondrej Hrdy; Milos Duba; Andrea Dolezelova; Ivana Roskova; Martin Hlavaty; Rudolf Traj; Vit Bönisch; Martin Smrcka; Roman Gal

doi:10.1186/s13741-023-00321-3

Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial

Perioper Med (Lond). 2023 Jul 5;12(1):32. doi: 10.1186/s13741-023-00321-3.

Authors

Ondrej Hrdy^{1

2}, Milos Duba^{3

4}, Andrea Dolezelova^{1

2}, Ivana Roskova^{5

6}, Martin Hlavaty^{1

2}, Rudolf Traj^{1

2}, Vit Bönisch^{1

2}, Martin Smrcka^{5

6}, Roman Gal^{1

2}

Affiliations

¹ Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic.
² Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
³ Department of Neurosurgery, University Hospital Brno, Brno, Czech Republic. duba.milos@fnbrno.cz.
⁴ Department of Neurosurgery, Faculty of Medicine, Masaryk University, Brno, Czech Republic. duba.milos@fnbrno.cz.
⁵ Department of Neurosurgery, University Hospital Brno, Brno, Czech Republic.
⁶ Department of Neurosurgery, Faculty of Medicine, Masaryk University, Brno, Czech Republic.

Abstract

Background: The positive effects of goal-directed hemodynamic therapy (GDHT) on patient-orientated outcomes have been demonstrated in various clinical scenarios; however, the effects of fluid management in neurosurgery remain unclear. Therefore, this study was aimed at assessing the safety and feasibility of GDHT using non-invasive hemodynamic monitoring in elective neurosurgery. The incidence of postoperative complications was compared between GDHT and control groups.

Methods: We conducted a single-center randomized pilot study with an enrollment target of 34 adult patients scheduled for elective neurosurgery. We randomly assigned the patients equally into control and GDHT groups. The control group received standard therapy during surgery and postoperatively, whereas the GDHT group received therapy guided by an algorithm based on non-invasive hemodynamic monitoring. In the GDHT group, we aimed to achieve and sustain an optimal cardiac index by using non-invasive hemodynamic monitoring and bolus administration of colloids and vasoactive drugs. The number of patients with adverse events, feasibility criteria, perioperative parameters, and incidence of postoperative complications was compared between groups.

Results: We successfully achieved all feasibility criteria. The GDHT protocol was safe, because no patients in either group had unsatisfactory brain tissue relaxation after surgery or brain edema requiring therapy during surgery or 24 h after surgery. Major complications occurred in two (11.8%) patients in the GDHT group and six (35.3%) patients in the control group (p = 0.105).

Conclusions: Our results suggested that a large randomized trial evaluating the effects of GDHT on the incidence of postoperative complications in elective neurosurgery should be safe and feasible. The rate of postoperative complications was comparable between groups.

Trial registration: Trial registration: ClininalTrials.gov, registration number: NCT04754295, date of registration: February 15, 2021.

Keywords: Complications; Goal-directed therapy; Hemodynamic monitoring; Neuro-anesthesia; Neurosurgery; Postoperative outcome.

Associated data

ClinicalTrials.gov/NCT04754295