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Clinical Trial

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

NCT: NCT03606941 · COMPLETED

NCT IDNCT03606941
StatusCOMPLETED
Start Date2018-09-07
Completion2022-10-31
SponsorTianjin Nankai Hospital (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

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

Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery is a clinical trial registered under NCT03606941. Current status: COMPLETED.

What is the status of NCT03606941?

The current status of NCT03606941 (Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery) is: COMPLETED.

When did Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery start?

Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery started on 2018-09-07.

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Official Source

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