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NCT Number: NCT03606941

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

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; 2) Secondary outcome:The effects on postoperative NRS pain and sleep quality scores;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:5 years.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Electroacupuncture Apparatus

Tianjin, Tianjin Municipality, 300100, China

About this study

This study is a multicenter, randomized, double-blinded, placebo-controlled 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 and the effects on postoperative NRS pain and sleep quality scores. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electroacupuncture treatment

Device

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 is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 5 mA (gradually increase to the patient's maximum tolerance) and maintained the end of operation.

sham electroacupuncture treatment

Device

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.

Primary outcomes

  1. The incidence of delirium within 5 days after surgery

    Time frame: preoperative and the first 5 consecutive days after surgery

    Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium

Secondary outcomes

  1. The effects on postoperative pain scores

    Time frame: preoperative and the first 5 consecutive days after surgery

    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)

  2. The effects on postoperative sleep quality scores

    Time frame: preoperative and the first 5 consecutive days after surgery.

    Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep)

  3. Length of stay in hospital after surgery

    Time frame: From the end of surgery to hospital discharge, assessed up to 30 days after surgery.

    Duration of postoperative hospitalization after surgery

  4. Incidence of non-delirium complications during the first 30 days after surgery (including re-hospitalization)

    Time frame: From the end of surgery through postoperative day 30.

    Incidence of postoperative complications other than delirium, including cardiac events, cerebrovascular events, renal injury, infection, and rehospitalization.

  5. All-cause 30-day mortality after surgery

    Time frame: From the end of surgery through postoperative day 30.

    All reasons (such as infection, hemorrhage) caused the mortality during the first 30 days after surgery

Sponsors and collaborators

Lead sponsor

Tianjin Nankai Hospital

Other

Collaborators

  • Affiliated Hospital of Nanjing University of Chinese Medicine
  • Characteristic Medical Center of the Chinese People's Armed Police Force
  • Clinical Medical College of Yangzhou University
  • First Affiliated Hospital of Fujian Medical University
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Liuzhou Traditional Chinese Medical Hospital
  • Tianjin Jinghai District Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2018
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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