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

April 11, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group maintain the target blood pressure only according to the controlled hypotension guideline.
Experimental: Experimental group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: through hospitalization period, an average of 15 day
Hospital stay
through hospitalization period, an average of 15 day
Hospital expenses
Time Frame: through hospitalization period, an average of 15 day
Hospital expenses
through hospitalization period, an average of 15 day
Perioperative complications
Time Frame: 1 day (during the surgical period)
Complications during the surgical period
1 day (during the surgical period)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcomes
Time Frame: through study completion, an average of 1 year
Complications and adverse reactions of patients during the study period
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2023

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2026

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-KY-009-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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