Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery
Condition: Postoperative Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      1. Title: Effect of electroacupuncture on the incidence of postoperative delirium in
           elderly patients undergoing the major surgery.

        2. Research center: Multicenter

        3. The Design of the study: Randomized, double-blind, controlled study

        4. 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.

        5. Sample size: Enroll 1100 patients (550 patients in each group)

        6. 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.

        7. 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.

        8. 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.

        9. The estimated duration of the study：3-4 years.
    

Detailed description: 
      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.
    

Intervention name(s): electroacupuncture treatment; sham electroacupuncture treatment
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: electroacupuncture; delirium; the elderly; surgery, major