AnesthesiaSTEADYNCT06161662
STimulation Electronically of Acupoints for Postoperative Delirium in elderlY Patients
A study testing transcutaneous electrical acupoint stimulation in people with Anesthesia and Postoperative Delirium, run by Zhihong LU at 1 site in China.
Trial summary
Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia, Postoperative Delirium, Electroencephalogram
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 30 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 years or older
- American Society of Anesthesiologists (ASA) classification≤ Grade III
- Patients scheduled for elective abdominal surgery under general anesthesia
- Informed consent
Who cannot join
- Patients with severe central nervous system injury or severe cerebrovascular disease
- Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery
- Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication
- Patients with severe hepatic and renal insufficiency
- Patients with severe respiratory diseases
- Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points
- Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of the Air Force Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium and EEG Characteristic Parameters in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia
Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.
- Conditions
- Anesthesia, Postoperative Delirium, Electroencephalogram
- Being tested
- transcutaneous electrical acupoint stimulation, Control
- Keywords
- Transcutaneous electrical acupoint stimulation, Postoperative delirium, Electroencephalogram
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationOther
Also called TEAS
Electrodes will be attached on the surface of acupoints and electrical stimulation will be given
ControlOther
Electrodes will be attached on the surface of acupoints but no stimulation will be given
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical stimulation | Experimental | At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and Shenmen point and connected to the percutaneous acupoint electrical stimulation device (Hwato , Suzhou Medical Equipment Factory). Electrical stimulation is given. Receives: Other: transcutaneous electrical acupoint stimulation |
| Control | Other | At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium by 7 days after surgery
Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method
Measured: from end of surgery to 7 days after surgery
Secondary outcomes (13)
electroencephalogram (EEG) alpha band power
Measured: From anesthesia induction to the end of surgery
Maximal decrease of regional cerebral oxygen saturation
Measured: From anesthesia induction to the end of surgery
Incidence of major complications
myocardial ischemia needing intervention, heart failure, respiratory failure, pneumonia, Coma, stroke, altered state of consciousness
Measured: From end of surgery to discharge from hospital, at an average of 7 days
The numerical rating scale of sleep quality
The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality
Measured: From end of surgery to 1 day after surgery
The numerical rating scale of pain
The scale is from 0 to 10. 0 is no pain, 10 is the worst pain
Measured: From end of surgery to 1 day after surgery
The numerical rating scale of sleep quality
The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality
Measured: From end of surgery to 3 days after surgery
The numerical rating scale of pain
The scale is from 0 to 10. 0 is no pain, 10 is the worst pain
Measured: From end of surgery to 3 days after surgery
The Quality of Recovery-15 Score by 3 days after surgery
Measured: From end of surgery to 3 days after surgery
Incidence of delirium by 1 day after surgery
Measured: From end of surgery to 1 day after surgery
Incidence of delirium by 3 days after surgery
Measured: From end of surgery to 3 days after surgery
opioid consumption for patient controlled analgesia
the consumption is converted to morphine equivalence
Measured: From end of surgery to 1 day after surgery
number of attempts for patient controlled analgesia
number of patients pressing the bolus button of the patient controlled analgesia device, indicating that the patient feel pain
Measured: From end of surgery to 1 day after surgery
total sleep time
Measured: From end of surgery to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start10 Jan 2024
- Primary completion8 Oct 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161662
- Sponsor's protocol ID
- XJH-A-20230920
- Acronym
- STEADY
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification
Publications
Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13.
PubMed 36130079Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.
PubMed 30565342
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium and EEG Characteristic Parameters in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06161662
- Acronym / sponsor ID
- STEADY / XJH-A-20230920
- Conditions
- Anesthesia, Postoperative Delirium, Electroencephalogram
- Keywords
- Transcutaneous electrical acupoint stimulation, Postoperative delirium, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical stimulation | Experimental | Other: transcutaneous electrical acupoint stimulationAt the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and Shenmen point and connected to the percutaneous acupoint electrical stimulation device (Hwato , Suzhou Medical Equipment Factory). Electrical stimulation is given. |
| Control | Other | Other: ControlAt the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 65 years or older
- American Society of Anesthesiologists (ASA) classification≤ Grade III
- Patients scheduled for elective abdominal surgery under general anesthesia
- Informed consent
Key exclusion criteria (7 listed)
- Patients with severe central nervous system injury or severe cerebrovascular disease
- Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery
- Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication
- Patients with severe hepatic and renal insufficiency
- Patients with severe respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical acupoint stimulationAlso: TEASElectrodes will be attached on the surface of acupoints and electrical stimulation will be given | Other | Transcutaneous electrical stimulation |
| ControlElectrodes will be attached on the surface of acupoints but no stimulation will be given | Other | Control |
Primary outcome
Incidence of delirium by 7 days after surgery
Time frame: from end of surgery to 7 days after surgery
Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method
13 secondary outcomes
electroencephalogram (EEG) alpha band power
Time frame: From anesthesia induction to the end of surgery
Maximal decrease of regional cerebral oxygen saturation
Time frame: From anesthesia induction to the end of surgery
Incidence of major complications
Time frame: From end of surgery to discharge from hospital, at an average of 7 days
The numerical rating scale of sleep quality
Time frame: From end of surgery to 1 day after surgery
The numerical rating scale of pain
Time frame: From end of surgery to 1 day after surgery
The numerical rating scale of sleep quality
Time frame: From end of surgery to 3 days after surgery
The numerical rating scale of pain
Time frame: From end of surgery to 3 days after surgery
The Quality of Recovery-15 Score by 3 days after surgery
Time frame: From end of surgery to 3 days after surgery
Incidence of delirium by 1 day after surgery
Time frame: From end of surgery to 1 day after surgery
Incidence of delirium by 3 days after surgery
Time frame: From end of surgery to 3 days after surgery
opioid consumption for patient controlled analgesia
Time frame: From end of surgery to 1 day after surgery
number of attempts for patient controlled analgesia
Time frame: From end of surgery to 1 day after surgery
total sleep time
Time frame: From end of surgery to 1 day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 36130079Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13.
- Background: PubMed 30565342Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.
- Individual participant dataSharing planned: Yes. individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with Anesthesia and Postoperative Delirium, run by Zhihong LU 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 10 Mar 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. 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?
Incidence of delirium by 7 days after surgery (time frame: from end of surgery to 7 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 NCT06161662, which also lists 2 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 10 Mar 2026.