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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963063
Recruitment Status : Completed
First Posted : May 24, 2019
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Anesthesia Procedure: Goal-directed fluid therapy Procedure: Non goal-directed fluid therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Perioperative Goal-directed Fluid Therapy in Preventing Cerebral Desaturation and Postoperative Cognitive Dysfunction After Beach Chair Position Shoulder Surgery
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963063


Locations
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Taiwan
Department of Anesthesiology, National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Chun-Yu Wu, Ph.D. National Taiwan University Hospital
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03963063    
Other Study ID Numbers: 201903017RINB
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Cognitive Complications
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
 Mental Disorders
Postoperative Complications
Pathologic Processes