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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2021-03-31

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.

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Detailed Description

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Conditions

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Postoperative Cognitive Dysfunction Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Non Goal-directed Care Group

Group Type ACTIVE_COMPARATOR

Non goal-directed fluid therapy

Intervention Type PROCEDURE

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

Goal-directed Care Group

Group Type EXPERIMENTAL

Goal-directed fluid therapy

Intervention Type PROCEDURE

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

Interventions

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Goal-directed fluid therapy

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

Intervention Type PROCEDURE

Non goal-directed fluid therapy

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No