Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus

NCT05535985 | Unknown

• 1 other identifier: SHOUFA 2022-2-2232
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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.

Conditions

Acupuncture; Postoperative Delirium (POD); Diabetes Mellitus

Keywords

Acupuncture; Postoperative delirium (POD); Diabetes Mellitus; Regional Cerebral Oxygen Saturation (rSO2)

Outcome Measures

Primary Outcomes (6)

• 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

• Incidence of postoperative delirium

  assess the incidence of postoperative delirium using 3D-CAM

  at 16 p.m. the day after surgery

• Incidence of postoperative delirium

  assess the incidence of postoperative delirium using 3D-CAM

  at 8 a.m. the second day after surgery

• Incidence of postoperative delirium

  assess the incidence of postoperative delirium using 3D-CAM

  at 16 p.m. the second day after surgery

• Incidence of postoperative delirium

  assess the incidence of postoperative delirium using 3D-CAM

  at 8 a.m. the third day after surgery

• Incidence of postoperative delirium

  assess the incidence of postoperative delirium using 3D-CAM

  at 16 p.m. the third day after surgery

Secondary Outcomes (10)

• Regional Saturation of Oxygenation (rSO2)

  baseline

• Regional Saturation of Oxygenation (rSO2)

  the time when tracheal intubation finished

• Regional Saturation of Oxygenation (rSO2)

  the time when the surgery begins

• Regional Saturation of Oxygenation (rSO2)

  1 hour after the beginning of the surgery

• Regional Saturation of Oxygenation (rSO2)

  the time when the surgery ends

Other Outcomes (3)

• Height

  The 1 day before surgery

• Weight

  The 1 day before surgery

• Mini-mental state examination (MMSE) score

  The 1 day before surgery

Study Arms (3)

acupuncture group

EXPERIMENTAL

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

placebo acupuncture group

PLACEBO COMPARATOR

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

control group

NO INTERVENTION

The patients will undergoing routine anesthesia without acupuncture treatment.

Interventions

acupuncture DEVICE

treatment of pain or disease by inserting the tips of needles at specific points on the skin

acupuncture group

placebo acupuncture DEVICE

placebo acupuncture

placebo acupuncture group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lingling Ding: lead

MeSH Terms

Conditions

Emergence Delirium; Diabetes Mellitus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lingling Ding, Doctor

  Beijing Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingling Ding, Doctor

CONTACT

+86 010 87906647; dinglingling301@126.com

Ruiling Zhou, Master

CONTACT

+86 010 87906647; 1652282940@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 10, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share