Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05535985
• Other study ID #: SHOUFA 2022-2-2232
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Lingling Ding, Doctor
• Phone: +86 010 87906647
• Email: dinglingling301[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. 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.

2. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 215
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Delirium
• Diabetes Mellitus
• Postoperative Delirium (POD)

Intervention

Device:
• acupuncture
treatment of pain or disease by inserting the tips of needles at specific points on the skin
• placebo acupuncture
placebo acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lingling Ding

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height	Record the height (in meters) of the patient	The 1 day before surgery
Other	Weight	Record the weight (in kilograms) of the patient	The 1 day before surgery
Other	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.	The 1 day before surgery
Primary	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
Primary	Incidence of postoperative delirium	assess the incidence of postoperative delirium using 3D-CAM	at 16 p.m. the day after surgery
Primary	Incidence of postoperative delirium	assess the incidence of postoperative delirium using 3D-CAM	at 8 a.m. the second day after surgery
Primary	Incidence of postoperative delirium	assess the incidence of postoperative delirium using 3D-CAM	at 16 p.m. the second day after surgery
Primary	Incidence of postoperative delirium	assess the incidence of postoperative delirium using 3D-CAM	at 8 a.m. the third day after surgery
Primary	Incidence of postoperative delirium	assess the incidence of postoperative delirium using 3D-CAM	at 16 p.m. the third day after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood glucose levels	record blood glucose levels	Entering the operating room, the time when the surgery ends
Secondary	Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100ß in serum	The inflammation level will be assessed.	Entering the operating room, the time when the surgery ends
Secondary	Expression of peroxisome proliferators-activated receptor-?coactivator-1a (PGC-1a)	assess the expression of PGC-1a	Entering the operating room, the time when the surgery ends