Delirium, PostoperativeNCT06360549
Effect of Percutaneous Acupoint Electrical Stimulation on Delirium
A study testing Transcutaneous Electrical Acupoint Stimulation in people with Delirium, Postoperative, run by Qin Zhang at 2 sites in China.
Trial summary
This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- Transcutaneous Electrical Acupoint Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2024to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study;
- Age ≥ 18 years;
- Patients scheduled for thoracoscopic lung resection surgery;
- ASA grade I-III.
Who cannot join
- History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
- History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
- Severe cardiovascular and cerebrovascular diseases;
- Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
- Pregnant or postpartum women;
- Patients with language communication barriers;
- Deemed unsuitable for participation by the researchers.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000
Jiemin Deng, 2780, qin4298@sina.com
Jiemin Deng
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Zhang, phd, 15717154768, qzhang8@tjh.tjmu.edu.cn
Qin Zhang, phd
About this study
Official title: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium After Thoracoscopic Pneumonectomy
This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium.
Read the detailed description
Transcutaneous Electrical Acupoint Stimulation (TEAS) is a treatment method that combines acupuncture point theory of traditional Chinese medicine with physical electrical stimulation techniques. It achieves the purpose of acupoint stimulation by applying a weak current to a specific part. Compared with traditional acupuncture, TEAS has the advantages of non-invasiveness, safety, portability and adjustability. Intraoperative acupoint electrical stimulation has no effect on operation and monitoring.
This multicenter, prospective, randomized controlled clinical trial aims to investigate the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on postoperative delirium following thoracoscopic pulmonary resection. The study design involves the randomized allocation of participants into two groups: an intervention group receiving percutaneous acupoint electrical stimulation and a control group undergoing standard postoperative care.
The intervention protocol includes the precise selection of acupoints for TEAS application, parameters for electrical stimulation, frequency of treatments, and duration of intervention sessions. Patients in the control group will receive conventional postoperative management without TEAS.
Outcome measures will assess plasma TK/MMP3 levels, incidence and severity of postoperative delirium, perioperative inflammatory markers, cognitive function, pain levels, anxiety, sleep patterns, postoperative complications, recovery quality, and hospital stay duration. Statistical analysis will employ appropriate methods to evaluate the effectiveness of TEAS in managing postoperative delirium.
Overall, this clinical trial seeks to contribute to the understanding of how TEAS may improve postoperative delirium management and patient outcomes following thoracoscopic pulmonary resection. The Detailed Description provides a comprehensive overview of the study protocol without duplicating information presented elsewhere in the document.
- Conditions
- Delirium, Postoperative
- Being tested
- Transcutaneous Electrical Acupoint Stimulation
- Keywords
- Delirium, Thoracoscopic lung resection surgery
- 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.
Transcutaneous Electrical Acupoint StimulationDevice
Transcutaneous Electrical Acupoint Stimulation (TEAS) is a treatment that combines acupoint theory of traditional Chinese medicine with modern electrical stimulation techniques. It achieves the purpose of acupoint stimulation by applying a weak current to a specific part. TEAS operate just like ordinary electrodes with non-invasive, safe, portable, adjustable and other advantages.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | No intervention | • Intrabronchial general anesthesia was used for anesthesia in all patients. Electrocardiogram (ECG), pulse oxygen saturation (SpO2), blood pressure (BP), body temperature (T), end-expiratory carbon dioxide (EtCO2), ventilators related parameters (VT, f, MV, etc.), and EEG monitoring (BIS) were routinely monitored during the operation. |
| Percutaneous acupoint electrical stimulation treatment group | Experimental | On the basis of the conventional treatment received by the control group, the following additional treatments were implemented: Patients assigned to the treatment group underwent acupuncture with electrode pieces placed on bilateral Sanyin jiao, bilateral Zusanli, bilateral Shenmen, Shenting, Yintang, bilateral Hegu, and bilateral Neiguan 30 minutes before anesthesia. The acupuncture involved electrical stimulation using a dense wave with a frequency of 2/100Hz. The stimulation intensity was adjusted to the maximum current tolerable by the patient, typically ranging from 1-7mA, and continued until the conclusion of the operation. Receives: Device: Transcutaneous Electrical Acupoint Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium (using the Delirium Rating Scale, DRS)
The Delirium Rating Scale (DRS) is a validated instrument used to assess the severity of delirium in individuals. The DRS total score ranges from 0 to 46, with higher scores indicating greater severity of delirium symptoms.
Measured: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery
Secondary outcomes (1)
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool that assesses various cognitive functions, including orientation, memory, attention, and language. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 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 posted11 Apr 2024
- Study start1 Mar 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group. Inclusion criteria: 1. Voluntarily sign informed consent; 2. Age ≥18 years old; 3. Patients undergoing thoracoscopic pneumonectomy; 4. ASA Grade I-III;
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
- Investigators
- Qin Zhang, phd, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360549
- Sponsor's protocol ID
- TJ-IRB202403019
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Percutaneous Acupoint Electrical Stimulation on Delirium After Thoracoscopic Pneumonectomy
- ClinicalTrials.gov ID
- NCT06360549
- Acronym / sponsor ID
- TJ-IRB202403019
- Conditions
- Delirium, Postoperative
- Keywords
- Delirium, Thoracoscopic lung resection surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Apr 2024 (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.
This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium.
Detailed description
Transcutaneous Electrical Acupoint Stimulation (TEAS) is a treatment method that combines acupuncture point theory of traditional Chinese medicine with physical electrical stimulation techniques. It achieves the purpose of acupoint stimulation by applying a weak current to a specific part. Compared with traditional acupuncture, TEAS has the advantages of non-invasiveness, safety, portability and adjustability. Intraoperative acupoint electrical stimulation has no effect on operation and monitoring.
This multicenter, prospective, randomized controlled clinical trial aims to investigate the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on postoperative delirium following thoracoscopic pulmonary resection. The study design involves the randomized allocation of participants into two groups: an intervention group receiving percutaneous acupoint electrical stimulation and a control group undergoing standard postoperative care.
The intervention protocol includes the precise selection of acupoints for TEAS application, parameters for electrical stimulation, frequency of treatments, and duration of intervention sessions. Patients in the control group will receive conventional postoperative management without TEAS.
Outcome measures will assess plasma TK/MMP3 levels, incidence and severity of postoperative delirium, perioperative inflammatory markers, cognitive function, pain levels, anxiety, sleep patterns, postoperative complications, recovery quality, and hospital stay duration. Statistical analysis will employ appropriate methods to evaluate the effectiveness of TEAS in managing postoperative delirium.
Overall, this clinical trial seeks to contribute to the understanding of how TEAS may improve postoperative delirium management and patient outcomes following thoracoscopic pulmonary resection. The Detailed Description provides a comprehensive overview of the study protocol without duplicating information presented elsewhere in the document.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group. Inclusion criteria: 1. Voluntarily sign informed consent; 2. Age ≥18 years old; 3. Patients undergoing thoracoscopic pneumonectomy; 4. ASA Grade I-III;
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | No intervention | –• Intrabronchial general anesthesia was used for anesthesia in all patients. Electrocardiogram (ECG), pulse oxygen saturation (SpO2), blood pressure (BP), body temperature (T), end-expiratory carbon dioxide (EtCO2), ventilators related parameters (VT, f, MV, etc.), and EEG monitoring (BIS) were routinely monitored during the operation. |
| Percutaneous acupoint electrical stimulation treatment group | Experimental | Device: Transcutaneous Electrical Acupoint StimulationOn the basis of the conventional treatment received by the control group, the following additional treatments were implemented: Patients assigned to the treatment group underwent acupuncture with electrode pieces placed on bilateral Sanyin jiao, bilateral Zusanli, bilateral Shenmen, Shenting, Yintang, bilateral Hegu, and bilateral Neiguan 30 minutes before anesthesia. The acupuncture involved electrical stimulation using a dense wave with a frequency of 2/100Hz. The stimulation intensity was adjusted to the maximum current tolerable by the patient, typically ranging from 1-7mA, and continued until the conclusion of the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary participation in the study;
- Age ≥ 18 years;
- Patients scheduled for thoracoscopic lung resection surgery;
- ASA grade I-III.
Key exclusion criteria (7 listed)
- History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
- History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
- Severe cardiovascular and cerebrovascular diseases;
- Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
- Pregnant or postpartum women;
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 StimulationTranscutaneous Electrical Acupoint Stimulation (TEAS) is a treatment that combines acupoint theory of traditional Chinese medicine with modern electrical stimulation techniques. It achieves the purpose of acupoint stimulation by applying a weak current to a specific part. TEAS operate just like ordinary electrodes with non-invasive, safe, portable, adjustable and other advantages. | Device | Percutaneous acupoint electrical stimulation treatment group |
Primary outcome
Delirium (using the Delirium Rating Scale, DRS)
Time frame: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery
The Delirium Rating Scale (DRS) is a validated instrument used to assess the severity of delirium in individuals. The DRS total score ranges from 0 to 46, with higher scores indicating greater severity of delirium symptoms.
1 secondary outcome
Mini-Mental State Examination (MMSE)
Time frame: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Qin Zhang, phd principal investigator
Tongji Hospital
2 sites 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 Delirium, Postoperative, run by Qin Zhang at 2 sites 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Ran, phd (15926207366, ranxiao1001@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (using the Delirium Rating Scale, DRS) (time frame: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 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 11 Apr 2024.