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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Oxygen Saturation, Postoperative Cognitive Function

Intervention / Treatment
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* Other: Controlled hypotension guided by cerebral oxygen saturation monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited patients 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group maintain the target blood pressure only according to the controlled hypotension guideline. | |
| Experimental: Experimental group<br>The experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. | Other: Controlled hypotension guided by cerebral oxygen saturation monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Expression changes of cognitive function related markers 24 hours after operation | Patients consented on blood sampling receive marker analysis from blood（S100β、NSE and IL-6). | 24 hours after operation | 
| Hospital stay | Hospital stay | through hospitalization period, an average of 15 day | 
| Hospital expenses | Hospital expenses | through hospitalization period, an average of 15 day | 
| Perioperative complications | Complications during the surgical period | 1 day (during the surgical period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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controlled hypotension