Volume Optimisation and Cognitive Function in Major Abdominal Surgery

NCT03186846 | Completed

• 1 other identifier: KME 21/11/16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cognitive decline; hemodynamic monitoring; LIDCO; INVOS; BIS; brain injury biomarkers

Outcome Measures

Primary Outcomes (1)

• Cognitive decline assessment change

  Blood samples for determination of brain injury biomarkers (NSE, S 100, GFAP, TAU, UCH-L1, MMP-9, miRNA, apo E4) before and at the end of operation. Cognitive function testing (Mini mental test): before the operation and on day 2 after the surgery.

  three days

Study Arms (2)

multimodal monitoring

ACTIVE COMPARATOR

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: multimodal monitoring

placebo

ACTIVE COMPARATOR

No multimodal monitoring will be applied in control group.

Device: placebo

Interventions

multimodal monitoring DEVICE

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.

Also known as: LiDCO Rapid, unilateral INVOS, unilateral BIS

multimodal monitoring

placebo DEVICE

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.

placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 2-3 patients,
• \> 18 years
• signed written consent for anesthesia and study participation
• Major abdominal surgery (stomach and intestin resection)
• epidural catheter insertion

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

Location

Related Publications (19)

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MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Alenka Spindler Vesel, MD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of anaesthesiology department for abdominal surgery

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: June 14, 2017
• Study Start: October 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

SL (1)