Electroacupuncture Apparatus
Tianjin, Tianjin Municipality, 300100, China
NCT Number: NCT03606941
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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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Tianjin, Tianjin Municipality, 300100, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: preoperative and the first 5 consecutive days after surgery
Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium
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)
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)
Time frame: From the end of surgery to hospital discharge, assessed up to 30 days after surgery.
Duration of postoperative hospitalization after surgery
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.
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
Tianjin Nankai Hospital
Other
Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery:a Prospective, Multicenter, Randomized Controlled Trial
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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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