Clinical trial NCT05615480: Effect of Cerebral Oxygen Saturation Monitoring on POCD of Elderly Patients Undergoing Shoulder Arthroscopy
Official title: Effect of Controlled Hypotension Guided by Cerebral Oxygen Saturation Monitoring on Postoperative Cognitive Function of Elderly Patients Undergoing Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Oxygen Saturation
Postoperative Cognitive Function
Keywords: controlled hypotension
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
timeFrame: 3 days after operation
Secondary outcomes:
measure: Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation
timeFrame: 14 days after operation
measure: Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation
timeFrame: 3 months after operation
measure: Expression changes of cognitive function related markers 24 hours after operation
timeFrame: 24 hours after operation
measure: Hospital stay
timeFrame: through hospitalization period, an average of 15 day
measure: Hospital expenses
timeFrame: through hospitalization period, an average of 15 day
measure: Perioperative complications
timeFrame: 1 day (during the surgical period)
Other outcomes:
measure: Safety outcomes
timeFrame: through study completion, an average of 1 year
Locations:
Study officials:
References:
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