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

January 5, 2022 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • Department of Anesthesiology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non Goal-directed Care Group
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
Experimental: Goal-directed Care Group
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of cerebral desaturation events
Time Frame: 3 hours
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
Time Frame: 3 hours
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
Time Frame: 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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Chun-Yu Wu, Ph.D., National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201903017RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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