Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery

Study Overview
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Brief Summary
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Title: Effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery. Research center: Multicenter The Design of the study: Randomized, double-blind, controlled study The population of the study: Elderly patients（65≤age<90 years），it is planned to select a period/time limit for gastrointestinal tumor surgery, bile duct surgery, thoracic surgery or orthopedic surgery and so on under general anesthesia, and the estimated operation time≥ 2 hours. Sample size: Enroll 1100 patients (550 patients in each group) Interventions: Participants in the treatment group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After Deqi, electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of operation. Participants in the control group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output. The aim of the research: To investigate the effect of electroacupuncture on the incidence of postoperative delirium within 5 days in elderly patients undergoing the major surgery. Outcome： 1) Primary outcome：The incidence of delirium within 5 days after surgery；The effects on postoperative NRS pain and sleep quality scores； 2)Secondary outcome：Duration of mechanical ventilation in patients with endotracheal intubation on ICU admission; Length of stay in ICU and Length of stay in hospital after surgery; Incidence of postoperative complications (including re-hospitalization); 30-day life quality and cognitive function after surgery; All-cause 30-day mortality after surgery. The estimated duration of the study：3-4 years.

Detailed Description
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This study is a large sample, randomized, double-blinded, placebo-controlled and long-term follow-up design. In this study, bilateral Shenmen, Neiguan, Baihui and Yintang acupoints were selected for perioperative electroacupuncture treatment, accompanied with evaluating the incidence of delirium within 5 days after surgery,the effects on postoperative NRS pain and sleep quality scores as well as the detection of blood biochemical indexes such as serum S100β, brain derived neurotrophic factor (BDNF), interleukin-6 and interleukin-8. To clarify the effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.

Official Title
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Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery：a Prospective, Multicenter, Double-blind, Randomized Controlled Trial

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Device: electroacupuncture treatment
* Device: sham electroacupuncture treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥65 and <90 years old； Planning to undergo select timed/limited surgery such as gastrointestinal tumor surgery, bile duct surgery and thoracic surgery etc under general anesthesia, and the estimated operation time is more than 2 hours;； Treatment without radiotherapy or chemotherapy prior to surgery； Agree to participate in this study and sign informed consent； Exclusion Criteria: Refuse to participate in this study； Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis； Inability to communicate in the preoperative period to complete preoperative evaluation because of severe dementia, coma, language barrier； Brain injury or neurosurgery； Critical condition (if the ASA grade is greater than or equal to grade IV before surgery); Severe renal impairment (dialysis treatment before surgery); Severe liver function impairment (Child-Pugh level C); Preoperative combined with severe heart disease, LVEF < 30%; Previous experience of acupoint stimulation therapy or non-insensitive to acupoint stimulation； The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture treatment<br>Participants in the treatment group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After Deqi, electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of operation. | Device: electroacupuncture treatment<br>* Participants in the electroacupuncture group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After Deqi, electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1   30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of operation.<br>|
| Sham Comparator: sham electroacupuncture treatment<br>Participants in the control group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output. | Device: sham electroacupuncture treatment<br>* Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output, and retained the needle until the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of delirium within 5 days after surgery | Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium | an average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation in patients with endotracheal intubation on ICU | Duration of mechanical ventilation and endotracheal intubation in ICU | an average of 1 year | 
| Length of stay in hospital after surgery | postoperative ICU stay time and hospitalization time | 12 months | 
| Incidence of non-delirium complications during the first 30 days after surgery (including re-hospitalization) | cardiac events, cerebrovascular events, renal injury, infections, etc | up to 1 year | 
| All-cause 30-day mortality after surgery | All reasons (such as infection, hemorrhage) caused the mortality during the first 30 days after surgery | 1 year | 
| The effects on postoperative pain scores | NRS method is used to evaluate the pain scores of patients (0 points to complete Painless, 10 points to the maximum pain that can be tolerated) | up to 12 months | 
| The effects on postoperative sleep quality scores | Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep) | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroacupuncture; delirium; the elderly; surgery, major