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

Primary Purpose

Cerebral Oxygen Saturation, Postoperative Cognitive Function

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Controlled hypotension guided by cerebral oxygen saturation monitoring
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Oxygen Saturation focused on measuring controlled hypotension

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Experimental group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Incidence of postoperative cognitive dysfunction(POCD) 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.
    Incidence of postoperative cognitive dysfunction(POCD) 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.
    Expression changes of cognitive function related markers 24 hours after operation
    Patients consented on blood sampling receive marker analysis from blood(S100β、NSE and IL-6).
    Hospital stay
    Hospital stay
    Hospital expenses
    Hospital expenses
    Perioperative complications
    Complications during the surgical period

    Full Information

    First Posted
    May 9, 2022
    Last Updated
    April 11, 2023
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05615480
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Oxygen Saturation, Postoperative Cognitive Function
    Keywords
    controlled hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group maintain the target blood pressure only according to the controlled hypotension guideline.
    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    The experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.
    Intervention Type
    Other
    Intervention Name(s)
    Controlled hypotension guided by cerebral oxygen saturation monitoring
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
    Description
    The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
    Time Frame
    3 days after operation
    Secondary Outcome Measure Information:
    Title
    Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation
    Description
    The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
    Time Frame
    14 days after operation
    Title
    Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation
    Description
    The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
    Time Frame
    3 months after operation
    Title
    Expression changes of cognitive function related markers 24 hours after operation
    Description
    Patients consented on blood sampling receive marker analysis from blood(S100β、NSE and IL-6).
    Time Frame
    24 hours after operation
    Title
    Hospital stay
    Description
    Hospital stay
    Time Frame
    through hospitalization period, an average of 15 day
    Title
    Hospital expenses
    Description
    Hospital expenses
    Time Frame
    through hospitalization period, an average of 15 day
    Title
    Perioperative complications
    Description
    Complications during the surgical period
    Time Frame
    1 day (during the surgical period)
    Other Pre-specified Outcome Measures:
    Title
    Safety outcomes
    Description
    Complications and adverse reactions of patients during the study period
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effect of Cerebral Oxygen Saturation Monitoring on POCD of Elderly Patients Undergoing Shoulder Arthroscopy

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