Volume Optimisation and Cognitive Function in Major Abdominal Surgery
NCT ID: NCT03186846
Last Updated: 2021-01-20
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-10-01
2019-08-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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
No multimodal monitoring will be applied in control group.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 18 years
* signed written consent for anesthesia and study participation
* Major abdominal surgery (stomach and intestin resection)
* epidural catheter insertion
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Alenka Spindler-Vesel
MD, PhD, Head of anaesthesiology department for abdominal surgery
Principal Investigators
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Alenka Spindler Vesel, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Ljubljana
Locations
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University Medical Centre
Ljubljana, , Slovenia
Countries
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References
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Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176.
Green D, Paklet L. Latest developments in peri-operative monitoring of the high-risk major surgery patient. Int J Surg. 2010;8(2):90-9. doi: 10.1016/j.ijsu.2009.12.004. Epub 2010 Jan 14.
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Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. doi: 10.1056/NEJMoa021108.
Walsh SR, Tang T, Bass S, Gaunt ME. Doppler-guided intra-operative fluid management during major abdominal surgery: systematic review and meta-analysis. Int J Clin Pract. 2008 Mar;62(3):466-70. doi: 10.1111/j.1742-1241.2007.01516.x. Epub 2007 Nov 21.
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Gurgel ST, do Nascimento P Jr. Maintaining tissue perfusion in high-risk surgical patients: a systematic review of randomized clinical trials. Anesth Analg. 2011 Jun;112(6):1384-91. doi: 10.1213/ANE.0b013e3182055384. Epub 2010 Dec 14.
Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
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.
Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
Bisgaard J, Gilsaa T, Ronholm 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.
Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording 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. doi: 10.1097/01.sla.0000094387.50865.23.
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Brandstrup B, Svendsen PE, Rasmussen M, Belhage B, Rodt SA, Hansen B, Moller 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.
Lobo SM, Ronchi LS, Oliveira NE, Brandao PG, Froes A, Cunrath GS, Nishiyama KG, Netinho JG, Lobo FR. Restrictive strategy of intraoperative fluid maintenance during optimization of oxygen delivery decreases major complications after high-risk surgery. Crit Care. 2011;15(5):R226. doi: 10.1186/cc10466. Epub 2011 Sep 23.
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Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.
Other Identifiers
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KME 21/11/16
Identifier Type: -
Identifier Source: org_study_id
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