Postoperative DeliriumNCT07045090
The Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
A study testing Transcutaneous electrical acupoint stimulation and Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation in people with Postoperative Delirium, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions 1. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Transcutaneous electrical acupoint stimulation and Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Nov 2024
- 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;
- Body mass index (BMI) 18-30 kg/m²;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Patients scheduled for elective laparoscopic gastrointestinal surgery;
- Willingness to provide written informed consent and comply with the treatment regimen;
- Absence of severe organic diseases, psychiatric disorders, or preoperative delirium.
Who cannot join
- Preoperative Mini-Mental State Examination (MMSE) score <20;
- Electrocardiographic evidence of severe bradycardia (heart rate <50 beats per minute);
- Presence of skin lesions or infections at the electrical stimulation site;
- History of preoperative chemotherapy or radiotherapy;
- Concomitant severe organic diseases with compromised tolerance to interventions;
- Prior exposure to Transcutaneous Electrical Acupoint Stimulation (TEAS) or transcutaneous auricular vagus nerve stimulation (taVNS) with documented insensitivity;
- Inability to communicate normally, dementia, hearing impairment, or severe psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions
- whether it reduces the expression of inflammatory factors in the acute postoperative period
- whether it can reduce the incidence of postoperative delirium
Read the detailed description
Existing clinical studies have shown that TEAS has demonstrated value in preventing postoperative delirium (POD). Currently, taVNS is commonly used clinically to improve patients' cognitive dysfunction (POCD), and POD is often considered a precursor to the development of POCD. However, no one has yet used the two in combination, so this study aimed to combine the two to investigate their potential benefits in preventing POD.
- Conditions
- Postoperative Delirium
- Being tested
- Transcutaneous electrical acupoint stimulation, Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation
- Keywords
- Elderly patients, postoperative delirium, gastrointestinal surgery, Auricular vagus nerve stimulation, Transcutaneous electrical acupoint stimulation
- 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 stimulationDevice
Before induction of anaesthesia, electrodes were attached to selected acupoints and energised for 30 min, with the electrical stimulation parameter of dispersed dense wave (2/100 Hz), and the current intensity was based on the maximum current intensity that could be tolerated by the patient.
Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulationDevice
Before anaesthesia induction, the electrodes were attached to the selected acupoints and energized for 30 min, with the electrical stimulation parameters of dispersed dense wave (2/100Hz), and the current intensity was based on the maximum current intensity that the patient could tolerate. At the same time, the left ear auricular region was stimulated with a fasciculus nerve stimulator, the electrical stimulation parameters were: pulse width of 250 μs, pulse frequency of 20Hz, every 30s on, 30s off, and then 30s on again, the current intensity was based on the maximum current intensity that the patient could tolerate, for 30min.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Prior to induction of anaesthesia, patients in this group received transcutaneous electrical stimulation of acupuncture points for 30 min, followed by standardised anaesthesia. Receives: Device: Transcutaneous electrical acupoint stimulation |
| Group B | Experimental | Prior to induction of anaesthesia, patients in this group received transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation for a total of 30 min, followed by standardised anaesthesia. Receives: Device: Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Whether delirium occurred after surgery（by 3D-CAM）
Measured: The first to third days after surgery
Secondary outcomes (5)
IL-6 andTNF-α level
the level of IL-6 andTNF-α in the participant's serum（by ELISA）
Measured: before operation（Before anesthesia），the end of the operation（Immediately after the sewing is finished）
VAS pain score
Assessed with a VAS score scale, the highest is 10 and the lowest is 0, the higher the more severe the pain
Measured: The first to third days after surgery
Early activities
The first time to be able to get out of bed and move
Measured: Post-operative period until discharge（in about a week）
Time to first postoperative anal defecation
Time to first postoperative anal defecation
Measured: Post-operative period until discharge（In about a week）
Adverse events
Nausea and vomiting, sore throat, itching
Measured: The first to third days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 May 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lulu Ji, Affiliated Hospital of Nantong University
- Investigators
- Lulu Ji, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045090
- Sponsor's protocol ID
- 2024-K071-01
- Status last verified
- Apr 2024
- First submitted
- 19 Feb 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPDs collected in the experiment were published only as the results of the paper
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT07045090
- Acronym / sponsor ID
- 2024-K071-01
- Conditions
- Postoperative Delirium
- Keywords
- Elderly patients, postoperative delirium, gastrointestinal surgery, Auricular vagus nerve stimulation, Transcutaneous electrical acupoint stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 1 Jul 2025 (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.
The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions
- whether it reduces the expression of inflammatory factors in the acute postoperative period
- whether it can reduce the incidence of postoperative delirium
Detailed description
Existing clinical studies have shown that TEAS has demonstrated value in preventing postoperative delirium (POD). Currently, taVNS is commonly used clinically to improve patients' cognitive dysfunction (POCD), and POD is often considered a precursor to the development of POCD. However, no one has yet used the two in combination, so this study aimed to combine the two to investigate their potential benefits in preventing POD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Transcutaneous electrical acupoint stimulationPrior to induction of anaesthesia, patients in this group received transcutaneous electrical stimulation of acupuncture points for 30 min, followed by standardised anaesthesia. |
| Group B | Experimental | Device: Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulationPrior to induction of anaesthesia, patients in this group received transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation for a total of 30 min, followed by standardised anaesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged ≥65 years;
- Body mass index (BMI) 18-30 kg/m²;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Patients scheduled for elective laparoscopic gastrointestinal surgery;
- Willingness to provide written informed consent and comply with the treatment regimen;
Key exclusion criteria (7 listed)
- Preoperative Mini-Mental State Examination (MMSE) score <20;
- Electrocardiographic evidence of severe bradycardia (heart rate <50 beats per minute);
- Presence of skin lesions or infections at the electrical stimulation site;
- History of preoperative chemotherapy or radiotherapy;
- Concomitant severe organic diseases with compromised tolerance to interventions;
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 stimulationBefore induction of anaesthesia, electrodes were attached to selected acupoints and energised for 30 min, with the electrical stimulation parameter of dispersed dense wave (2/100 Hz), and the current intensity was based on the maximum current intensity that could be tolerated by the patient. | Device | Group A |
| Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulationBefore anaesthesia induction, the electrodes were attached to the selected acupoints and energized for 30 min, with the electrical stimulation parameters of dispersed dense wave (2/100Hz), and the current intensity was based on the maximum current intensity that the patient could tolerate. At the same time, the left ear auricular region was stimulated with a fasciculus nerve stimulator, the electrical stimulation parameters were: pulse width of 250 μs, pulse frequency of 20Hz, every 30s on, 30s off, and then 30s on again, the current intensity was based on the maximum current intensity that the patient could tolerate, for 30min. | Device | Group B |
Primary outcome
Incidence of postoperative delirium
Time frame: The first to third days after surgery
Whether delirium occurred after surgery（by 3D-CAM）
5 secondary outcomes
IL-6 andTNF-α level
Time frame: before operation（Before anesthesia），the end of the operation（Immediately after the sewing is finished）
VAS pain score
Time frame: The first to third days after surgery
Early activities
Time frame: Post-operative period until discharge（in about a week）
Time to first postoperative anal defecation
Time frame: Post-operative period until discharge（In about a week）
Adverse events
Time frame: The first to third days 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 1 Jul 2025.
- Individual participant dataSharing planned: No. The IPDs collected in the experiment were published only as the results of the paper
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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.
Lulu Ji study director
Affiliated Hospital of Nantong University
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 and Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation in people with Postoperative Delirium, run by Affiliated Hospital of Nantong University 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 6 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 1 Jul 2025. 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 postoperative delirium (time frame: The first to third days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.