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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Not yet enrolling

Conditions

Postoperative Cognitive Function
Cerebral Oxygen Saturation

Treatments

Other: Controlled hypotension guided by cerebral oxygen saturation monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT05615480
2021-KY-009-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

60 to 79 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

400 participants in 2 patient groups

Control group
No Intervention group
Description:
The control group maintain the target blood pressure only according to the controlled hypotension guideline.
Experimental group
Experimental group
Description:
The experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.
Treatment:
Other: Controlled hypotension guided by cerebral oxygen saturation monitoring

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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