Volume Optimisation and Cognitive Function in Major Abdominal Surgery

Summary

In the last 25 years, there has been a lot of attention directed on reducing perioperative morbidity and mortality by improving intraoperative monitoring and hemodynamic optimisation of patients. Advanced monitoring devices and new parameters have shifted the focus of anaesthesia management from macro- to micro circulation with the emphasis on the determinants of oxygen delivery and tissue oxygenation. There is increasing evidence that long-term outcome is improved by goal-directed optimisation of hemodynamic parameters (optimisation of stroke volume and cardiac output by fluids and inotropic and vasoactive drugs). Besides, new monitoring possibilities (depth of anaesthesia and cerebral and tissue oxygenation monitors) and adherence to protocols have proved beneficial in reducing morbidity cognitive dysfunction.

However, questions are raised what the optimal goals (healthy population derived normal values, preoperative values, maximal values, restrictive fluid management) should be. Secondly, all new methods were used separately and there is a lack of studies to show the effect of combined (multimodal) monitoring on occurrence of cognitive dysfunction. All gathered data indicate that the combined use of new methods with adherence to an appropriate protocol might radically improve the perioperative management and outcome of high-risk surgical patients.

The present study tests the hypothesis that intraoperative multimodal monitoring with hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen saturation will reduce cognitive dysfunction.

Conditions

• Cognitive Decline

Interventions

DEVICE

multimodal monitoring

LiDCO Rapid, unilateral INVOS and unilateral BIS monitors will be applied. Should there be pre-existing carotid stenosis, INVOS sensor will be applied on the same side. In case of pre-existing cerebral pathology, the INVOS sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS, mean arterial pressure (MAP) and regional oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation which raises the value. • Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy.

DEVICE

placebo

Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy.

Sponsors & Collaborators

• University Medical Centre Ljubljana

  lead OTHER

Principal Investigators

• Alenka Spindler Vesel, MD · University Medical Centre Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2019-06-01

Completion

2019-08-01

Countries

• Slovenia

Study Locations