NCT03963063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 27, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

January 21, 2022

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

May 21, 2019

Last Update Submit

January 5, 2022

Conditions

Postoperative Cognitive DysfunctionAnesthesia

Outcome Measures

Primary Outcomes (1)

  • duration of cerebral desaturation events

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

    3 hours

Secondary Outcomes (2)

  • incidence of cerebral desaturation events

    3 hours

  • postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci

    3 days

Study Arms (2)

Non Goal-directed Care Group

ACTIVE COMPARATOR
Procedure: Non goal-directed fluid therapy

Goal-directed Care Group

EXPERIMENTAL
Procedure: Goal-directed fluid therapy

Interventions

Goal-directed fluid therapyPROCEDURE

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

Goal-directed Care Group
Non goal-directed fluid therapyPROCEDURE

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

Non Goal-directed Care Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving scheduled beach chair position shoulder surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (8)

  • 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.

    PMID: 30348620BACKGROUND

  • 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.

    PMID: 26675953BACKGROUND

  • 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.

    PMID: 26846619RESULT

  • 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.

    PMID: 24119783RESULT

  • 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.

    PMID: 30292739RESULT

  • 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.

    PMID: 26503361RESULT

  • 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.

    PMID: 29678619RESULT

  • 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.

    PMID: 36135341DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Chun-Yu Wu, Ph.D.

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 24, 2019

Study Start

June 27, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

January 21, 2022

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)