Clinical trial NCT03963063: Neurological Effects of Goal-directed Fluid Therapy in Beach Chair Position Shoulder Surgery
Official title: Efficacy of Perioperative Goal-directed Fluid Therapy in Preventing Cerebral Desaturation and Postoperative Cognitive Dysfunction After Beach Chair Position Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: duration of cerebral desaturation events
timeFrame: 3 hours
Secondary outcomes:
measure: incidence of cerebral desaturation events
timeFrame: 3 hours
measure: postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci
timeFrame: 3 days
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Department of Anesthesiology, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu, Ph.D.
role: STUDY_DIRECTOR
References:
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citation: Aguirre JA, Etzensperger F, Brada M, Guzzella S, Saporito A, Blumenthal S, Buhler P, Borgeat A. The beach chair position for shoulder surgery in intravenous general anesthesia and controlled hypotension: Impact on cerebral oxygenation, cerebral blood flow and neurobehavioral outcome. J Clin Anesth. 2019 Mar;53:40-48. doi: 10.1016/j.jclinane.2018.09.035. Epub 2018 Oct 4.
citation: Ni C, Xu T, Li N, Tian Y, Han Y, Xue Q, Li M, Guo X. Cerebral oxygen saturation after multiple perioperative influential factors predicts the occurrence of postoperative cognitive dysfunction. BMC Anesthesiol. 2015 Oct 26;15:156. doi: 10.1186/s12871-015-0117-6.
citation: Zhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17.
citation: Lee CT, Lin CP, Chan KC, Wu YL, Teng HC, Wu CY. Effects of Goal-Directed Hemodynamic Therapy Using a Noninvasive Finger-Cuff Monitoring Device on Intraoperative Cerebral Oxygenation and Early Delayed Neurocognitive Recovery in Patients Undergoing Beach Chair Position Shoulder Surgery: A Randomized Controlled Trial. Anesth Analg. 2023 Feb 1;136(2):355-364. doi: 10.1213/ANE.0000000000006200. Epub 2022 Sep 22.