An interventional study of acupuncture and placebo acupuncture in Acupuncture, Postoperative Delirium (POD) and Diabetes Mellitus, sponsored by Lingling Ding. Status unknown. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-14.
Sponsored by Lingling Ding · Not applicable, Interventional, and Prevention
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.
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This study's planned enrollment of 215 is above the median of 120 across 599 interventional studies indexed under Delirium.
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Exclusion Criteria:
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
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
The patients will undergoing routine anesthesia without acupuncture treatment.
treatment of pain or disease by inserting the tips of needles at specific points on the skin
placebo acupuncture
Incidence of postoperative delirium
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
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Time frame: at 16 p.m. the day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Time frame: at 8 a.m. the second day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Time frame: at 16 p.m. the second day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Time frame: at 8 a.m. the third day after surgery
Incidence of postoperative delirium
assess the incidence of postoperative delirium using 3D-CAM
Time frame: at 16 p.m. the third day after 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 8 a.m. and 16 p.m. daily for 3 days after surgery
Blood glucose levels
record blood glucose levels
Time frame: 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.
Time frame: 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
Time frame: Entering the operating room, the time when the surgery ends
Height
Record the height (in meters) of the patient
Time frame: The 1 day before surgery
Weight
Record the weight (in kilograms) of the patient
Time frame: The 1 day before surgery
Mini-mental state examination (MMSE) score
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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