Neurological Effects of Goal-directed Fluid Therapy in Beach Chair Position Shoulder Surgery

Study Overview
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Brief Summary
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Patients receiving beach chair position shoulder surgery are vulnerable to perioperative cerebral desaturation, which is reported to be a risk factor for postoperative cognitive dysfunction. Investigators design this study to test the efficacy of perioperative goal-directed therapy in preventing cerebral desaturation and postoperative cognitive dysfunction in patients receiving beach chair position shoulder surgery.

Official Title
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Efficacy of Perioperative Goal-directed Fluid Therapy in Preventing Cerebral Desaturation and Postoperative Cognitive Dysfunction After Beach Chair Position Shoulder Surgery

Conditions
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Postoperative Cognitive Dysfunction, Anesthesia

Intervention / Treatment
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* Procedure: Goal-directed fluid therapy
* Procedure: Non goal-directed fluid therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients receiving scheduled beach chair position shoulder surgery Exclusion Criteria: pregnant women patients in intensive care units patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%] patients with heart failure(NYHA score =III、IV) patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2) patients with liver failure patients with ongoing infection patients allergic to voluven

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non Goal-directed Care Group<br> | Procedure: Non goal-directed fluid therapy<br>* Patients in the group will receive standard perioperative care at the discretion of care-giving anesthesiologist, maintaining: keep mean arterial pressure ≧65 mmHg keep systolic blood pressure ≦140 mmHg<br>|
| Experimental: Goal-directed Care Group<br> | Procedure: Goal-directed fluid therapy<br>* Patients in the group will follow our mini-fluid challenge test goal-directed therapy protocol, maintaining: individualized optimised stroke volume by mini-fluid challenge first keep mean arterial pressure ≧65 mmHg keep systolic blood pressure ≦140 mmHg keep cardiac index ≧ 2.5 L/min/cm2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of cerebral desaturation events | patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cerebral desaturation events | patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the incidence of cerebral desaturation events | 3 hours | 
| postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci | Qmci is a screening assessment developed to detect mild cognitive impairment. It's a 100-point test administered in approximately 10 minutes. A score of 60 or over is considered to be normal. The validity of the Taiwan version of Qmci has been established. | 3 days |