Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05535985
• Lead Sponsor: Lingling Ding

Brief 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.

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-14
• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	at 16 p.m. the third day after surgery	assess the incidence of postoperative delirium using 3D-CAM

Secondary Outcome Measures

Name	Time	Method
Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)	Entering the operating room, the time when the surgery ends	assess the expression of PGC-1α
Blood glucose levels	Entering the operating room, the time when the surgery ends	record blood glucose levels
Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum	Entering the operating room, the time when the surgery ends	The inflammation level will be assessed.
Regional Saturation of Oxygenation (rSO2)	Intraoperative	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)	at 8 a.m. and 16 p.m. daily for 3 days after surgery	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.