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

NCT03606941 | Completed

• 1 other identifier: NKYY_YX_IRB_2017_036_02
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Title: Effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery.
2. 2.Research center: Multicenter
3. 3.The Design of the study: Randomized, double-blind, controlled study
4. 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. 5.Sample size: Enroll 1100 patients (550 patients in each group)
6. 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. 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. 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. 9.The estimated duration of the study：3-4 years.

Conditions

Postoperative Delirium

Keywords

electroacupuncture; delirium; the elderly; surgery, major

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of mechanical ventilation in patients with endotracheal intubation on ICU

  an average of 1 year

• Length of stay in hospital after surgery

  12 months

• Incidence of non-delirium complications during the first 30 days after surgery (including re-hospitalization)

  up to 1 year

• All-cause 30-day mortality after surgery

  1 year

• The effects on postoperative pain scores

  up to 12 months

Study Arms (2)

electroacupuncture treatment

EXPERIMENTAL

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.

Device: electroacupuncture treatment

sham electroacupuncture treatment

SHAM COMPARATOR

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.

Device: sham electroacupuncture treatment

Interventions

electroacupuncture treatment DEVICE

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.

electroacupuncture treatment

sham electroacupuncture treatment DEVICE

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.

sham electroacupuncture treatment

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age≥65 and \<90 years old；
• 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;；
• Treatment without radiotherapy or chemotherapy prior to surgery；
• Agree to participate in this study and sign informed consent；

You may not qualify if:

• Refuse to participate in this study；
• Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis；
• Inability to communicate in the preoperative period to complete preoperative evaluation 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 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%;
• Previous experience of acupoint stimulation therapy or non-insensitive to acupoint stimulation；
• The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Electroacupuncture Apparatus

Tianjin, Tianjin Municipality, 300100, China

Location

Related Publications (24)

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MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jianbo Yu, MD,PhD

  Tianjin Nankai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 31, 2018
• Study Start: September 7, 2018
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)