Postoperative Delirium
Conditions
Keywords
electroacupuncture; delirium; the elderly; surgery, major
Brief 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； 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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Tianjin Nankai Hospital
Affiliated Hospital of Nanjing University of Chinese Medicine
Characteristic Medical Center of the Chinese People's Armed Police Force
First Affiliated Hospital of Fujian Medical University
Liuzhou Traditional Chinese Medical Hospital
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Clinical Medical College of Yangzhou University
Tianjin Jinghai District Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥65 and \<90 years old； 2. 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;； 3. Treatment without radiotherapy or chemotherapy prior to surgery； 4. Agree to participate in this study and sign informed consent；
Exclusion criteria
1. Refuse to participate in this study； 2. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis； 3. Inability to communicate in the preoperative period to complete preoperative evaluation because of severe dementia, coma, language barrier； 4. Brain injury or neurosurgery； 5. 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%; 6. Previous experience of acupoint stimulation therapy or non-insensitive to acupoint stimulation； 7. The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of delirium within 5 days after surgery | preoperative and the first 5 consecutive days after surgery | Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effects on postoperative pain scores | 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) |
| The effects on postoperative sleep quality scores | 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) |
| Length of stay in hospital after surgery | From the end of surgery to hospital discharge, assessed up to 30 days after surgery. | Duration of postoperative hospitalization after surgery |
| Incidence of non-delirium complications during the first 30 days after surgery (including re-hospitalization) | 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. |
| All-cause 30-day mortality after surgery | 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 |
Countries
China
Contacts
STUDY_CHAIRJianbo Yu, MD,PhD
Tianjin Nankai Hospital
Outcome results
None listed