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

Primary Purpose

Postoperative Cognitive Dysfunction, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Goal-directed fluid therapy
Non goal-directed fluid therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non Goal-directed Care Group

Goal-directed Care Group

Arm Description

Outcomes

Primary Outcome Measures

duration of cerebral desaturation events
patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events

Secondary Outcome Measures

incidence of cerebral desaturation events
patients 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 Qmci
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.

Full Information

First Posted
May 21, 2019
Last Updated
January 5, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03963063
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction, Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non Goal-directed Care Group
Arm Type
Active Comparator
Arm Title
Goal-directed Care Group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Goal-directed fluid therapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Non goal-directed fluid therapy
Intervention Description
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 Outcome Measure Information:
Title
duration of cerebral desaturation events
Description
patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
incidence of cerebral desaturation events
Description
patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the incidence of cerebral desaturation events
Time Frame
3 hours
Title
postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology, National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30348620
Citation
Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19.
Results Reference
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PubMed Identifier
26675953
Citation
Rappold T, Laflam A, Hori D, Brown C, Brandt J, Mintz CD, Sieber F, Gottschalk A, Yenokyan G, Everett A, Hogue CW. Evidence of an association between brain cellular injury and cognitive decline after non-cardiac surgery. Br J Anaesth. 2016 Jan;116(1):83-9. doi: 10.1093/bja/aev415.
Results Reference
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PubMed Identifier
26846619
Citation
Meex I, Vundelinckx J, Buyse K, Deburggraeve F, De Naeyer S, Desloovere V, Anne L, Truijen J, Vander Laenen M, Heylen R, De Deyne C, Jans F. Cerebral tissue oxygen saturation values in volunteers and patients in the lateral decubitus and beach chair positions: a prospective observational study. Can J Anaesth. 2016 May;63(5):537-43. doi: 10.1007/s12630-016-0604-3. Epub 2016 Feb 4.
Results Reference
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PubMed Identifier
24119783
Citation
Aguirre J, Borgeat A, Trachsel T, Cobo Del Prado I, De Andres J, Buhler P. Cerebral oxygenation in patients undergoing shoulder surgery in beach chair position: comparing general to regional anesthesia and the impact on neurobehavioral outcome. Rev Esp Anestesiol Reanim. 2014 Feb;61(2):64-72. doi: 10.1016/j.redar.2013.08.002. Epub 2013 Oct 9.
Results Reference
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PubMed Identifier
30292739
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.
Results Reference
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PubMed Identifier
26503361
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.
Results Reference
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PubMed Identifier
29678619
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.
Results Reference
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PubMed Identifier
36135341
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.
Results Reference
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Neurological Effects of Goal-directed Fluid Therapy in Beach Chair Position Shoulder Surgery

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