Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

Lingling Ding

Status: Not yet enrolling

Conditions: Postoperative Delirium (POD); Diabetes Mellitus; Acupuncture

Treatments: Device: placebo acupuncture; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05535985

SHOUFA 2022-2-2232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

215 participants in 3 patient groups, including a placebo group

acupuncture group

Experimental group

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.

Treatment:

Device: acupuncture

placebo acupuncture group

Placebo Comparator group

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.

Treatment:

Device: placebo acupuncture

control group

No Intervention group

Description:

The patients will undergoing routine anesthesia without acupuncture treatment.