Volume Optimisation and Cognitive Function in Major Abdominal Surgery

Cognitive Decline Clinical Trial

Official title:

Influence of Volume Optimisation on Cognitive Function in Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186846
• Other study ID #: KME 21/11/16
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2021
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

BACKGROUND There is increasing evidence that intraoperative aesthetic management influences outcomes. (5). Besides this the occurrence of low MAP, low minimum alveolar concentration (MAC) and low bispectral index (BIS) increased hospital stay and mortality.

Conventional intraoperative monitoring can result in occult low levels of blood flow and oxygen delivery that lead to complications that only occur days or weeks following surgery and give false re-assurance to the anaesthetist that he or she is doing a "good job". Advanced monitoring devices and new parameters have shifted the focus of anaesthesia management from macro- to microcirculation with the emphasis on the determinants of oxygen delivery and tissue oxygenation. There are more and more trials showing that introduction of new monitors and treatment protocols with predefined treatment limits or targets (goal-directed optimisation of hemodynamic parameters) improves long-term patient outcome and reduces morbidity and mortality by over 50%. Several studies have shown benefit when individualised; targeted oxygen delivery algorithms incorporating both fluid resuscitation and vasoactive drugs were used with high-risk surgical patients. The measurement of regional cerebral oxygen saturation can predict cognitive dysfunction after cardiac surgery. BIS monitoring facilitates anaesthetic titration, and reduced anaesthetic exposure and decreased the risk of postoperative cognitive dysfunction. There is reduction in strokes, less mechanical ventilation and shorter length of stay (LOS) with the use of INVOS.

However, all new methods have been studied separately and there is a lack of studies to show the effect of combined (multimodal) monitoring on mortality and occurrence of complications, including cognitive decline. All gathered data indicate that the combined use of new methods (assessment of fluid status, depth of anaesthesia and tissue oxygenation) with adherence to appropriate protocol might radically improve perioperative management and outcome of high-risk surgical patients.

Besides, questions are raised what the optimal goals (healthy population derived normal values, preoperative values, maximal values) should be. Lately, studies have shown that optimising cardiac output and oxygen delivery to higher (supra-normal) values intra- and postoperatively did not affect post-operative complications rate, intensive care unit stay or hospital length of stay. Probably the target should be maintaining patient's blood flow and oxygen delivery at preinduction levels. The question was also raised in fluid management. Liberal approach can lead to oedema of the intestines and other tissues, which may be responsible for poor tissue healing and other complications. In abdominal surgery, protocol-based fluid restriction reduced the incidence of perioperative complications such as cardiopulmonary events and disturbances of bowel motility while improving wound and anastomotic healing and reducing hospital stay in comparison to liberal fluid management. One of the trials has shown 52% lower rate of major postoperative complications in restrictive group than in the conventional group.

HYPOTHESIS 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 decline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• ASA 2-3 patients,

• > 18 years

• signed written consent for anesthesia and study participation

• Major abdominal surgery (stomach and intestin resection)

• epidural catheter insertion

Exclusion Criteria:

• pregnant women

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (19)

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Bisgaard J, Gilsaa T, Rønholm E, Toft P. Optimising stroke volume and oxygen delivery in abdominal aortic surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2013 Feb;57(2):178-88. doi: 10.1111/j.1399-6576.2012.02756.x. Epub 2012 Aug 17. — View Citation

Brandstrup B, Svendsen PE, Rasmussen M, Belhage B, Rodt SÅ, Hansen B, Møller DR, Lundbech LB, Andersen N, Berg V, Thomassen N, Andersen ST, Simonsen L. Which goal for fluid therapy during colorectal surgery is followed by the best outcome: near-maximal stroke volume or zero fluid balance? Br J Anaesth. 2012 Aug;109(2):191-9. doi: 10.1093/bja/aes163. Epub 2012 Jun 17. — View Citation

Brandstrup B, Tønnesen H, Beier-Holgersen R, Hjortsø E, Ørding H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. — View Citation

Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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