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

NCT ID: NCT05615480

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-06-30

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.

Conditions

Cerebral Oxygen Saturation; Postoperative Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

The control group maintain the target blood pressure only according to the controlled hypotension guideline.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

The experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.

Group Type: EXPERIMENTAL

Controlled hypotension guided by cerebral oxygen saturation monitoring

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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Other Identifiers

2021-KY-009-001

Identifier Type: -

Identifier Source: org_study_id