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

Phase

N/A

Condition

Dementia

Treatment

N/A

Clinical Study ID

NCT03606941

NKYY_YX_IRB_2017_036_02

Ages 65-90
All Genders

Study Summary

Title: Effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery.
Research center: Multicenter
The Design of the study: Randomized, double-blind, controlled study
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.
Sample size: Enroll 1100 patients (550 patients in each group)
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.
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.
Outcome： 1) Primary outcome：The incidence of delirium within 5 days after surgery；The effects on postoperative NRS pain and sleep quality scores； 2)Secondary outcome：Duration 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.
The estimated duration of the study：3-4 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age≥65 and <90 years old；
Planning to undergo select timed/limited surgery such as gastrointestinal tumorsurgery, bile duct surgery and thoracic surgery etc under general anesthesia, and theestimated 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

Exclusion Criteria:

Refuse to participate in this study；
Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myastheniagravis；
Inability to communicate in the preoperative period to complete preoperativeevaluation 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 beforesurgery); Severe renal impairment (dialysis treatment before surgery); Severe liverfunction impairment (Child-Pugh level C); Preoperative combined with severe heartdisease, LVEF < 30%;
Previous experience of acupoint stimulation therapy or non-insensitive to acupointstimulation；
The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.

Study Design

September 07, 2018

October 31, 2022

Study 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 S100β, 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.

Connect with a study center

Electroacupuncture Apparatus
Tianjin, Tianjin 300100
China
Site Not Available

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