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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963063
• Other study ID #: 201903017RINB
• Status: Completed
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Procedure:
• Goal-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
• Non 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

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Aguirre J, Borgeat A, Trachsel T, Cobo Del Prado I, De Andrés J, Bühler 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 An — View Citation

Aguirre JA, Etzensperger F, Brada M, Guzzella S, Saporito A, Blumenthal S, Bühler P, Borgeat A. The beach chair position for shoulder surgery in intravenous general anesthesia and controlled hypotension: Impact on cerebral oxygenation, cerebral blood flow — View 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. Review. — View Citation

Meex I, Vundelinckx J, Buyse K, Deburggraeve F, De Naeyer S, Desloovere V, Anné 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 posit — View 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/s12871-015-0 — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence of cerebral desaturation events	patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the incidence of cerebral desaturation events	3 hours
Secondary	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.	3 days