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

NCT05615480 | Not Yet Recruiting

• 1 other identifier: 2021-KY-009-001
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Oxygen Saturation; Postoperative Cognitive Function

Keywords

controlled hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation

  14 days after operation

• Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation

  3 months after operation

• Expression changes of cognitive function related markers 24 hours after operation

  24 hours after operation

• Hospital stay

  through hospitalization period, an average of 15 day

• Hospital expenses

  through hospitalization period, an average of 15 day

Other Outcomes (1)

• Safety outcomes

  through study completion, an average of 1 year

Study Arms (2)

Control group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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

Interventions

Controlled hypotension guided by cerebral oxygen saturation monitoring 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.

Experimental group

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Related Publications (14)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study, different researchers will be responsible for randomization, anesthesia and visit. A researcher is responsible for assigning random numbers to ensure the randomness of the study groups. Due to the intraoperative monitoring of cerebral oxygen saturation in the experimental group, it is impossible to blind the researchers implementing anesthesia. In order to ensure that the whole study is not affected by subjective factors, the visiting researchers are blinded, who do not know the anesthesia grouping, and are responsible for case enrollment screening, signing informed consent, preoperative and postoperative cognitive function evaluation, postoperative pain evaluation, complications and safety evaluation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: November 14, 2022
• Study Start: May 15, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share