Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

Conditions
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Postoperative Delirium (POD), Acupuncture, Diabetes Mellitus

Intervention / Treatment
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* Device: acupuncture
* Device: placebo acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture group<br>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. | Device: acupuncture<br>* treatment of pain or disease by inserting the tips of needles at specific points on the skin<br>|
| Placebo Comparator: placebo acupuncture group<br>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. | Device: placebo acupuncture<br>* placebo acupuncture<br>|
| No Intervention: control group<br>The patients will undergoing routine anesthesia without acupuncture treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium | assess the incidence of postoperative delirium using the 3-minute diagnostic confusion assessment method (3D-CAM) | at 8 a.m. the day after surgery | 
| Incidence of postoperative delirium | assess the incidence of postoperative delirium using 3D-CAM | at 16 p.m. the day after surgery | 
| Incidence of postoperative delirium | assess the incidence of postoperative delirium using 3D-CAM | at 8 a.m. the second day after surgery | 
| Incidence of postoperative delirium | assess the incidence of postoperative delirium using 3D-CAM | at 16 p.m. the second day after surgery | 
| Incidence of postoperative delirium | assess the incidence of postoperative delirium using 3D-CAM | at 8 a.m. the third day after surgery | 
| Incidence of postoperative delirium | assess the incidence of postoperative delirium using 3D-CAM | at 16 p.m. the third day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 
| 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. | the time when tracheal intubation finished | 
| 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. | the time when the surgery begins | 
| 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. | 1 hour after the beginning of the 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. | the time when the surgery ends | 
| 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. | Intraoperative | 
| 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. | at 8 a.m. and 16 p.m. daily for 3 days after surgery | 
| Blood glucose levels | record blood glucose levels | Entering the operating room, the time when the surgery ends | 
| Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum | The inflammation level will be assessed. | Entering the operating room, the time when the surgery ends | 
| Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α) | assess the expression of PGC-1α | Entering the operating room, the time when the surgery ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Postoperative delirium (POD), Diabetes Mellitus, Regional Cerebral Oxygen Saturation (rSO2)