Clinical trial NCT05535985: Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
Official title: A Prospective Randomized Controlled Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Postoperative Delirium (POD)
Diabetes Mellitus
Keywords: Acupuncture
Postoperative delirium (POD)
Diabetes Mellitus
Regional Cerebral Oxygen Saturation (rSO2)
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 215
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: at 8 a.m. the day after surgery
measure: Incidence of postoperative delirium
timeFrame: at 16 p.m. the day after surgery
measure: Incidence of postoperative delirium
timeFrame: at 8 a.m. the second day after surgery
measure: Incidence of postoperative delirium
timeFrame: at 16 p.m. the second day after surgery
measure: Incidence of postoperative delirium
timeFrame: at 8 a.m. the third day after surgery
measure: Incidence of postoperative delirium
timeFrame: at 16 p.m. the third day after surgery
Secondary outcomes:
measure: Regional Saturation of Oxygenation (rSO2)
timeFrame: baseline
measure: Regional Saturation of Oxygenation (rSO2)
timeFrame: the time when tracheal intubation finished
measure: Regional Saturation of Oxygenation (rSO2)
timeFrame: the time when the surgery begins
measure: Regional Saturation of Oxygenation (rSO2)
timeFrame: 1 hour after the beginning of the surgery
measure: Regional Saturation of Oxygenation (rSO2)
timeFrame: the time when the surgery ends
measure: Regional Saturation of Oxygenation (rSO2)
timeFrame: Intraoperative
measure: Visual Analogue Score (VAS)
timeFrame: at 8 a.m. and 16 p.m. daily for 3 days after surgery
measure: Blood glucose levels
timeFrame: Entering the operating room, the time when the surgery ends
measure: Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum
timeFrame: Entering the operating room, the time when the surgery ends
measure: Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)
timeFrame: Entering the operating room, the time when the surgery ends
Other outcomes:
measure: Height
timeFrame: The 1 day before surgery
measure: Weight
timeFrame: The 1 day before surgery
measure: Mini-mental state examination (MMSE) score
timeFrame: The 1 day before surgery
Locations:
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Lingling Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: