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Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

Primary Purpose

Acupuncture, Postoperative Delirium (POD), Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
placebo acupuncture
Sponsored by
Lingling Ding
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acupuncture focused on measuring Acupuncture, Postoperative delirium (POD), Diabetes Mellitus, Regional Cerebral Oxygen Saturation (rSO2)

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing general anesthesia in our hospital
  • Expected duration of operation >2h
  • Ages 18-60
  • With type 2 diabetes
  • American Society of Anesthesiologists (ASA) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
  • Expected postoperative hospital stay >3 days
  • No history of cerebrovascular accident in the past six months
  • The informed consent signed

Exclusion Criteria:

  • Unable or unwilling to cooperate with cognitive function scale tests
  • MMSE score <24
  • Refuse acupuncture treatment or have a history of needle sickness
  • With skin damage at the acupuncture sites
  • Coagulation dysfunction
  • Participated in other clinical studies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    acupuncture group

    placebo acupuncture group

    control group

    Arm Description

    In the acupuncture group, acupoints of Baihui, Shenting, Sishencong will be selected for acupuncture stimulation be anesthesia. The needle will be kept for 30 minutes, during which the needle will be performed once every 10 minutes for 10 seconds each time, 4 times in total. The therapist will give the subject verbal cues before and during the needle manipulation.

    The patients will be treated with consolation needle. Choose treatment of points that near but without going through the acupoints(upper arm deltoid muscle). Use the Park needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time and number of needles will be the same as those in the acupuncture group. The therapist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.

    The patients will undergoing routine anesthesia without acupuncture treatment.

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative delirium
    assess the incidence of postoperative delirium using the 3-minute diagnostic confusion assessment method (3D-CAM)
    Incidence of postoperative delirium
    assess the incidence of postoperative delirium using 3D-CAM
    Incidence of postoperative delirium
    assess the incidence of postoperative delirium using 3D-CAM
    Incidence of postoperative delirium
    assess the incidence of postoperative delirium using 3D-CAM
    Incidence of postoperative delirium
    assess the incidence of postoperative delirium using 3D-CAM
    Incidence of postoperative delirium
    assess the incidence of postoperative delirium using 3D-CAM

    Secondary Outcome Measures

    Regional Saturation of Oxygenation (rSO2)
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Regional Saturation of Oxygenation (rSO2)
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Regional Saturation of Oxygenation (rSO2)
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Regional Saturation of Oxygenation (rSO2)
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Regional Saturation of Oxygenation (rSO2)
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Regional Saturation of Oxygenation (rSO2)
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Visual Analogue Score (VAS)
    Record VAS. VAS is a psychometric response score. Draw a 10 cm horizontal line on the paper. The end of the line is 0, indicating no pain; the other end is 10, indicating severe pain. The middle part shows different levels of pain.
    Blood glucose levels
    record blood glucose levels
    Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum
    The inflammation level will be assessed.
    Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)
    assess the expression of PGC-1α

    Full Information

    First Posted
    September 1, 2022
    Last Updated
    September 9, 2022
    Sponsor
    Lingling Ding
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05535985
    Brief Title
    Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
    Official Title
    A Prospective Randomized Controlled Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lingling Ding

    4. Oversight

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

    5. Study Description

    Brief Summary
    To evaluate the effectiveness and safety of acupuncture on POD in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional Chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical basis for further promotion of integrated traditional Chinese and western medicine anesthesia in the future. To investigate the relationship between POD and rSO2 in diabetic patients undergoing surgery. To clarify the predictive value of intraoperative rSO2 monitoring on postoperative cognitive function in patients with diabetes, and to explore the effect of acupuncture on cerebral blood flow perfusion in patients with diabetes.
    Detailed Description
    Postoperative delirium (POD) increases the risk of postoperative dementia and mortality. Cognitive decline is common in patients with diabetes mellitus. As an independent risk factor for POD, diabetes significantly increases postoperative dementia and mortality. Our team found that acupuncture can reduce the incidence of POD in elderly patients, increase regional cerebral oxygen saturation (rSO2), and increase cerebral blood flow perfusion in diabetic patients. In this study, a prospective randomized controlled study with placebo acupuncture will be conducted. Diabetic patients undergoing elective surgery will be divided into acupuncture group, placebo acupuncture group and control group. Acupuncture will be used as the intervention method, and the incidence of POD will be the main therapeutic effect evaluation index to explore the efficacy of acupuncture in the prevention and treatment of POD in diabetic patients undergoing surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acupuncture, Postoperative Delirium (POD), Diabetes Mellitus
    Keywords
    Acupuncture, Postoperative delirium (POD), Diabetes Mellitus, Regional Cerebral Oxygen Saturation (rSO2)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    acupuncture group
    Arm Type
    Experimental
    Arm Description
    In the acupuncture group, acupoints of Baihui, Shenting, Sishencong will be selected for acupuncture stimulation be anesthesia. The needle will be kept for 30 minutes, during which the needle will be performed once every 10 minutes for 10 seconds each time, 4 times in total. The therapist will give the subject verbal cues before and during the needle manipulation.
    Arm Title
    placebo acupuncture group
    Arm Type
    Placebo Comparator
    Arm Description
    The patients will be treated with consolation needle. Choose treatment of points that near but without going through the acupoints(upper arm deltoid muscle). Use the Park needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time and number of needles will be the same as those in the acupuncture group. The therapist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The patients will undergoing routine anesthesia without acupuncture treatment.
    Intervention Type
    Device
    Intervention Name(s)
    acupuncture
    Intervention Description
    treatment of pain or disease by inserting the tips of needles at specific points on the skin
    Intervention Type
    Device
    Intervention Name(s)
    placebo acupuncture
    Intervention Description
    placebo acupuncture
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative delirium
    Description
    assess the incidence of postoperative delirium using the 3-minute diagnostic confusion assessment method (3D-CAM)
    Time Frame
    at 8 a.m. the day after surgery
    Title
    Incidence of postoperative delirium
    Description
    assess the incidence of postoperative delirium using 3D-CAM
    Time Frame
    at 16 p.m. the day after surgery
    Title
    Incidence of postoperative delirium
    Description
    assess the incidence of postoperative delirium using 3D-CAM
    Time Frame
    at 8 a.m. the second day after surgery
    Title
    Incidence of postoperative delirium
    Description
    assess the incidence of postoperative delirium using 3D-CAM
    Time Frame
    at 16 p.m. the second day after surgery
    Title
    Incidence of postoperative delirium
    Description
    assess the incidence of postoperative delirium using 3D-CAM
    Time Frame
    at 8 a.m. the third day after surgery
    Title
    Incidence of postoperative delirium
    Description
    assess the incidence of postoperative delirium using 3D-CAM
    Time Frame
    at 16 p.m. the third day after surgery
    Secondary Outcome Measure Information:
    Title
    Regional Saturation of Oxygenation (rSO2)
    Description
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Time Frame
    baseline
    Title
    Regional Saturation of Oxygenation (rSO2)
    Description
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Time Frame
    the time when tracheal intubation finished
    Title
    Regional Saturation of Oxygenation (rSO2)
    Description
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Time Frame
    the time when the surgery begins
    Title
    Regional Saturation of Oxygenation (rSO2)
    Description
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Time Frame
    1 hour after the beginning of the surgery
    Title
    Regional Saturation of Oxygenation (rSO2)
    Description
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Time Frame
    the time when the surgery ends
    Title
    Regional Saturation of Oxygenation (rSO2)
    Description
    The brain oxygen saturation monitoring electrode was attached to the forehead, and the baseline level (T0) was recorded after the reading was stable under the condition of air inhalation. rSO2 readings were recorded after induction (T1), at the beginning of surgery (T2), one hour after the beginning of surgery (T3), at the end of surgery (T4), and after extubation (T5). The maximum and minimum values of rSO2 readings during surgery were recorded, and the area under the rSO2 curve was recorded when the rSO2 reading decreased by 13% from baseline for more than 5 minutes. rSO2 values of each time point, maximum and minimum values during surgery.
    Time Frame
    Intraoperative
    Title
    Visual Analogue Score (VAS)
    Description
    Record VAS. VAS is a psychometric response score. Draw a 10 cm horizontal line on the paper. The end of the line is 0, indicating no pain; the other end is 10, indicating severe pain. The middle part shows different levels of pain.
    Time Frame
    at 8 a.m. and 16 p.m. daily for 3 days after surgery
    Title
    Blood glucose levels
    Description
    record blood glucose levels
    Time Frame
    Entering the operating room, the time when the surgery ends
    Title
    Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum
    Description
    The inflammation level will be assessed.
    Time Frame
    Entering the operating room, the time when the surgery ends
    Title
    Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)
    Description
    assess the expression of PGC-1α
    Time Frame
    Entering the operating room, the time when the surgery ends
    Other Pre-specified Outcome Measures:
    Title
    Height
    Description
    Record the height (in meters) of the patient
    Time Frame
    The 1 day before surgery
    Title
    Weight
    Description
    Record the weight (in kilograms) of the patient
    Time Frame
    The 1 day before surgery
    Title
    Mini-mental state examination (MMSE) score
    Description
    Scores are measured by the MMSE, with a maximum score of 30, a score between 27 and 30 is considered normal cognitive function, and a score less than 27 is considered cognitive dysfunction.
    Time Frame
    The 1 day before surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing general anesthesia in our hospital Expected duration of operation >2h Ages 18-60 With type 2 diabetes American Society of Anesthesiologists (ASA) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities; Expected postoperative hospital stay >3 days No history of cerebrovascular accident in the past six months The informed consent signed Exclusion Criteria: Unable or unwilling to cooperate with cognitive function scale tests MMSE score <24 Refuse acupuncture treatment or have a history of needle sickness With skin damage at the acupuncture sites Coagulation dysfunction Participated in other clinical studies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lingling Ding, Doctor
    Phone
    +86 010 87906647
    Email
    dinglingling301@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ruiling Zhou, Master
    Phone
    +86 010 87906647
    Email
    1652282940@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lingling Ding, Doctor
    Organizational Affiliation
    Beijing Hospital of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

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