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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606941
• Other study ID #: NKYY_YX_IRB_2017_036_02
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Tianjin Nankai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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；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.

9. The estimated duration of the study：3-4 years.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Device:
• electroacupuncture treatment
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 (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of operation.
• sham electroacupuncture treatment
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.

Locations

Country	Name	City	State
China	Electroacupuncture Apparatus	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

References & Publications (24)

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Bickel H, Gradinger R, Kochs E, Förstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24. — View Citation

Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. Review. — View Citation

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Lin R, Li X, Liu W, Chen W, Yu K, Zhao C, Huang J, Yang S, Peng H, Tao J, Chen L. Electro-acupuncture ameliorates cognitive impairment via improvement of brain-derived neurotropic factor-mediated hippocampal synaptic plasticity in cerebral ischemia-reperf — View Citation

Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress — View Citation

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Zhang Q, Li YN, Guo YY, Yin CP, Gao F, Xin X, Huo SP, Wang XL, Wang QJ. Effects of preconditioning of electro-acupuncture on postoperative cognitive dysfunction in elderly: A prospective, randomized, controlled trial. Medicine (Baltimore). 2017 Jun;96(26) — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of delirium within 5 days after surgery	Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium	an average of one year
Secondary	Duration of mechanical ventilation in patients with endotracheal intubation on ICU	Duration of mechanical ventilation and endotracheal intubation in ICU	an average of 1 year
Secondary	Length of stay in hospital after surgery	postoperative ICU stay time and hospitalization time	12 months
Secondary	Incidence of non-delirium complications during the first 30 days after surgery (including re-hospitalization)	cardiac events, cerebrovascular events, renal injury, infections, etc	up to 1 year
Secondary	All-cause 30-day mortality after surgery	All reasons (such as infection, hemorrhage) caused the mortality during the first 30 days after surgery	1 year
Secondary	The effects on postoperative pain scores	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)	up to 12 months
Secondary	The effects on postoperative sleep quality scores	Using the NRS method (0 for the best quality of sleep and 10 for the worst quality of sleep)	up to one year