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Postoperative DeliriumNCT03606941

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

A study testing electroacupuncture treatment in people with Postoperative Delirium, run by Tianjin Nankai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 90 years
Conditions the study is for
Postoperative Delirium
What is being tested?
electroacupuncture treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,100 participants
Where
1 siteChina
Study dates
7 Sep 2018to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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；

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Electroacupuncture Apparatus

    Tianjin, Tianjin Municipality, 300100

Other trials in China

About this study

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

  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.
Read the detailed description

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.

Being tested
electroacupuncture treatment, sham electroacupuncture treatment
Keywords
electroacupuncture; delirium; the elderly; surgery, major
Medical subject headings
Emergence Delirium, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroacupuncture treatmentDevice

    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.

  • sham electroacupuncture treatmentDevice

    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.

Study groups in NCT03606941
Study groupRoleWhat they receive
electroacupuncture treatmentExperimentalParticipants 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 (Hwato, DSZ-III, Suzhou Medical Supplies Factory Co. LTD) is connected and maintained the end of operation.
Receives: Device: electroacupuncture treatment
sham electroacupuncture treatmentSham comparatorParticipants 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.
Receives: Device: sham electroacupuncture treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of delirium within 5 days after surgery

    Using confusion assessment method (CAM) or CAM-ICU methods to assess delirium

    Measured: preoperative and the first 5 consecutive days after surgery

Secondary outcomes (5)

  1. 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)

    Measured: preoperative and the first 5 consecutive days after surgery

  2. 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)

    Measured: preoperative and the first 5 consecutive days after surgery.

  3. Length of stay in hospital after surgery

    Duration of postoperative hospitalization after surgery

    Measured: From the end of surgery to hospital discharge, assessed up to 30 days after surgery.

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

    Incidence of postoperative complications other than delirium, including cardiac events, cerebrovascular events, renal injury, infection, and rehospitalization.

    Measured: From the end of surgery through postoperative day 30.

  5. All-cause 30-day mortality after surgery

    All reasons (such as infection, hemorrhage) caused the mortality during the first 30 days after surgery

    Measured: From the end of surgery through postoperative day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start7 Sep 2018
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606941
Sponsor's protocol ID
NKYY_YX_IRB_2017_036_02
Other IDs
TJYXZDXK-3-013B, Z-2017-24-2504
Status last verified
Jun 2026
First submitted
2 Jul 2018
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.

    PubMed 28973626

  • Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.

    PubMed 19106695

  • Naeije G, Pepersack T. Delirium in elderly people. Lancet. 2014 Jun 14;383(9934):2044-2045. doi: 10.1016/S0140-6736(14)60993-4. No abstract available.

    PubMed 24931688

  • Morandi A, Jackson JC. Delirium in the intensive care unit: a review. Neurol Clin. 2011 Nov;29(4):749-63. doi: 10.1016/j.ncl.2011.08.004.

    PubMed 22032658

  • Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.

    PubMed 11797025

  • Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.

    PubMed 20069607

  • Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4.

    PubMed 10335730

  • Franco K, Litaker D, Locala J, Bronson D. The cost of delirium in the surgical patient. Psychosomatics. 2001 Jan-Feb;42(1):68-73. doi: 10.1176/appi.psy.42.1.68.

    PubMed 11161124

  • Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.

    PubMed 15071384

  • Bickel H, Gradinger R, Kochs E, Forstl 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.

    PubMed 18577850

  • Balas MC, Happ MB, Yang W, Chelluri L, Richmond T. Outcomes Associated With Delirium in Older Patients in Surgical ICUs. Chest. 2009 Jan;135(1):18-25. doi: 10.1378/chest.08-1456. Epub 2008 Nov 18.

    PubMed 19017895

  • Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.

    PubMed 19745202

  • Avidan MS, Maybrier HR, Abdallah AB, Jacobsohn E, Vlisides PE, Pryor KO, Veselis RA, Grocott HP, Emmert DA, Rogers EM, Downey RJ, Yulico H, Noh GJ, Lee YH, Waszynski CM, Arya VK, Pagel PS, Hudetz JA, Muench MR, Fritz BA, Waberski W, Inouye SK, Mashour GA; PODCAST Research Group. Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial. Lancet. 2017 Jul 15;390(10091):267-275. doi: 10.1016/S0140-6736(17)31467-8. Epub 2017 May 30.

    PubMed 28576285

  • Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.

    PubMed 27542303

  • Sieber FE. Postoperative delirium in the elderly surgical patient. Anesthesiol Clin. 2009 Sep;27(3):451-64, table of contents. doi: 10.1016/j.anclin.2009.07.009.

    PubMed 19825486

Questions about this trial

What is this clinical trial studying?

A study testing electroacupuncture treatment in people with Postoperative Delirium, run by Tianjin Nankai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of delirium within 5 days after surgery (time frame: preoperative and the first 5 consecutive days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606941, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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