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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03963063
Enrollment
70
Registered
2019-05-24
Start date
2019-06-27
Completion date
2021-03-31
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Postoperative Cognitive Dysfunction

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.

Interventions

PROCEDUREGoal-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

PROCEDURENon 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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
duration of cerebral desaturation events3 hourspatients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events

Secondary

MeasureTime frameDescription
incidence of cerebral desaturation events3 hourspatients 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 Qmci3 daysQmci 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026