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

Not Applicable

Not yet recruiting

• Conditions: Cerebral Oxygen Saturation; Postoperative Cognitive Function
• Interventions: Other: Controlled hypotension guided by cerebral oxygen saturation monitoring

• Registration Number: NCT05615480
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Study Start: 2023-05-15
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Controlled hypotension guided by cerebral oxygen saturation monitoring	The experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation	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.

Secondary Outcome Measures

Name	Time	Method
Hospital expenses	through hospitalization period, an average of 15 day	Hospital expenses
Perioperative complications	1 day (during the surgical period)	Complications during the surgical period
Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation	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.
Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation	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.
Expression changes of cognitive function related markers 24 hours after operation	24 hours after operation	Patients consented on blood sampling receive marker analysis from blood（S100β、NSE and IL-6).
Hospital stay	through hospitalization period, an average of 15 day	Hospital stay