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

Not Applicable

Completed

• Conditions: Postoperative Cognitive Dysfunction; Anesthesia
• Interventions: Procedure: Non goal-directed fluid therapy; Procedure: Goal-directed fluid therapy

• Registration Number: NCT03963063
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Study Start: 2019-06-27
• Status Verified: 2020-10
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients receiving scheduled beach chair position shoulder surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Goal-directed Care Group	Non goal-directed fluid therapy	-
Goal-directed Care Group	Goal-directed fluid therapy	-

Primary Outcome Measures

Name	Time	Method
duration of cerebral desaturation events	3 hours	patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events

Secondary Outcome Measures

Name	Time	Method
incidence of cerebral desaturation events	3 hours	patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the incidence of cerebral desaturation events
postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci	3 days	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.

Trial Locations

Locations (1)

Department of Anesthesiology, National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan