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Completed

NCT Number: NCT03963063

Neurological Effects of Goal-directed Fluid Therapy in 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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Anesthesia Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal-Directed Fluid Therapy

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

Non goal-directed fluid therapy

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 24, 2019
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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