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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    1100
  • sponsor
    Tianjin Nankai Hospital
Updated on 26 August 2021
anesthesia
mechanical ventilation
orthopedic surgery
major surgery
postoperative complication

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 patients65age<90 yearsit 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 1700 patients (850 patients in each group)
  6. Interventions: Participants in the treatment group received acupuncture (0.30mm70mm) 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 (0.30mm25mm) 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 outcomeThe incidence of delirium within 5 days after surgeryThe effects on postoperative NRS pain and sleep quality scores 2)Secondary outcomeDuration 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 study3-4 years.

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 S100, 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.

Details
Condition Postoperative Delirium
Treatment electroacupuncture treatment, sham electroacupuncture treatment
Clinical Study IdentifierNCT03606941
SponsorTianjin Nankai Hospital
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age65 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
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