Effect of Cerebral Oxygen Saturation Monitoring on POCD of Elderly Patients Undergoing Shoulder Arthroscopy

Cerebral Oxygen Saturation Clinical Trial

Official title:

Effect of Controlled Hypotension Guided by Cerebral Oxygen Saturation Monitoring on Postoperative Cognitive Function of Elderly Patients Undergoing Shoulder Arthroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05615480
• Other study ID #: 2021-KY-009-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe whether adjusting the level of intraoperative controlled hypotension through cerebral oxygen saturation monitoring can improve postoperative cognitive function(POCD) and reduce postoperative neurological complications, a prospective randomized controlled study method will be used in this study. 400 elderly patients undergoing shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block will be selected. They will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.

Description:

Cognitive function will be evaluated within 3 days before operation and 3 days, 14 days and 3 months after operation. Delirium and VAS pain score will be evaluated 24 hours after operation. Venous blood will be taken before operation and 24 hours after operation to detect cognitive related markers and inflammatory factors. In addition, 10 blood samples of patients in each group were selected for RNA omics test. One month, six months and 12 months after operation, cognitive function was evaluated by cognitive function telephone questionnaire (TICS-M), and the ability of daily living was evaluated by IDAL. In addition, 20 non-surgical patients were selected for cognitive function evaluation at the same time point as the exercise effect of POCD detection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block;
• ASA grade = grade III;
• Patients Can communicate normally, can cooperate and complete cognitive function test;
• Patients volunteered and signed informed consent.

Exclusion Criteria:

• BMI < 18 or > 27 kg / m2;
• Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc;
• Patients taking sedatives or antidepressants;
• Alcoholics or drug addicts;
• Illiteracy, severe hearing or visual impairment;
• Patients with cognitive impairment before operation (MMSE score < 23);
• Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization;
• Patients unable to carry out long-term follow-up or poor compliance.

Related Conditions & MeSH terms

• Cerebral Oxygen Saturation
• Hypotension
• Postoperative Cognitive Function

Intervention

Other:
• Controlled hypotension guided by cerebral oxygen saturation monitoring
In this group, intraoperative monitoring of cerebral oxygen saturation will be used. When the cerebral oxygen saturation decreased by 20% ~ 25% compared with the baseline for 300 seconds without improvement, or the cerebral oxygen saturation decreased by 25% ~ 30% compared with the baseline for 180 seconds without improvement, intervention would be carried out. When the cerebral oxygen saturation decreased by 30% compared with the baseline, immediate intervention would be carried out. The intervention measures were intravenous administration of deoxyepinephrine 50 ~ 100 µg or ephedrine 5 ~ 10mg, which can be administered multiple times until the cerebral oxygen saturation reaches more than 80% of the baseline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

References & Publications (14)

Cox RM, Jamgochian GC, Nicholson K, Wong JC, Namdari S, Abboud JA. The effectiveness of cerebral oxygenation monitoring during arthroscopic shoulder surgery in the beach chair position: a randomized blinded study. J Shoulder Elbow Surg. 2018 Apr;27(4):692-700. doi: 10.1016/j.jse.2017.11.004. Epub 2018 Feb 1. — View Citation

Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729. — View Citation

de Tournay-Jette E, Dupuis G, Bherer L, Deschamps A, Cartier R, Denault A. The relationship between cerebral oxygen saturation changes and postoperative cognitive dysfunction in elderly patients after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):95-104. doi: 10.1053/j.jvca.2010.03.019. Epub 2010 Jul 22. — View Citation

Erdem AF, Kayabasoglu G, Tas Tuna A, Palabiyik O, Tomak Y, Beyaz SG. Effect of controlled hypotension on regional cerebral oxygen saturation during rhinoplasty: a prospective study. J Clin Monit Comput. 2016 Oct;30(5):655-60. doi: 10.1007/s10877-015-9768-6. Epub 2015 Sep 10. — View Citation

Evered LA, Silbert BS, Scott DA, Maruff P, Ames D. Prevalence of Dementia 7.5 Years after Coronary Artery Bypass Graft Surgery. Anesthesiology. 2016 Jul;125(1):62-71. doi: 10.1097/ALN.0000000000001143. — View Citation

Kim J, Shim JK, Song JW, Kim EK, Kwak YL. Postoperative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery. Anesth Analg. 2016 Aug;123(2):436-44. doi: 10.1213/ANE.0000000000001352. — View Citation

Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12. — View Citation

Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0. Erratum In: Lancet 1998 Jun 6;351(9117):1742. — View Citation

Needham MJ, Webb CE, Bryden DC. Postoperative cognitive dysfunction and dementia: what we need to know and do. Br J Anaesth. 2017 Dec 1;119(suppl_1):i115-i125. doi: 10.1093/bja/aex354. — View Citation

Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803. — View Citation

Nilsson PM. The J-shaped curve in secondary prevention: shall clinical practice change? Hypertension. 2012 Jan;59(1):8-9. doi: 10.1161/HYPERTENSIONAHA.111.182774. Epub 2011 Nov 7. No abstract available. — View Citation

Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15. — View Citation

Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569. — View Citation

Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcomes	Complications and adverse reactions of patients during the study period	through study completion, an average of 1 year
Primary	Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation	The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.	3 days after operation
Secondary	Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation	The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.	14 days after operation
Secondary	Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation	The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.	3 months after operation
Secondary	Expression changes of cognitive function related markers 24 hours after operation	Patients consented on blood sampling receive marker analysis from blood(S100ß?NSE and IL-6).	24 hours after operation
Secondary	Hospital stay	Hospital stay	through hospitalization period, an average of 15 day
Secondary	Hospital expenses	Hospital expenses	through hospitalization period, an average of 15 day
Secondary	Perioperative complications	Complications during the surgical period	1 day (during the surgical period)