Post-operative Cognitive DysfunctionNCT04338555
Effects of TEAS on POCD
A study testing Transcutaneous electrical acupoint stimulation in people with Post-operative Cognitive Dysfunction, run by RenJi Hospital at 1 site in China.
Trial summary
Patients undergoing elective orthopedics, urology, and general surgery will be included and randomly allocated to TEAS group or control group . After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Post-operative Cognitive Dysfunction
- What is being tested?
- Transcutaneous electrical acupoint stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2021to 26 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≧ 60 years old;
- communicate normally；
- ASA Physical Status 1-2;
- Patients will have elective orthopedics, urology or general surgeries under general anesthesia;
- With an estimated surgery time of more than 2h;
- Agree to participate the trial.
Who cannot join
- Patients with brain diseases or history of brain diseases;
- Preoperative diagnosis of cognitive impairment by subtle mental state (MMSE) less than 24 points;
- Patients with history of neurological and psychological disorders including AD, stroke, and psychosis;
- Severe hearing or visual impairment, illiteracy;
- preoperative systolic blood pressure >190mmHg, or diastolic blood pressure >100mmHg;
- Disagree to participate in this research;
- Have used other medical electronic devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutanclus Electrical Acupoint Stimulation on Postoperative Cognitive Dysfunction in Elderly Patients
Patients undergoing elective orthopedics, urology, and general surgery will be included and randomly allocated to TEAS group or control group . After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.
Read the detailed description
This study will enroll 110 patients who are older than 60 years old and will have elective orthopedics, urology, or general surgeries under general anesthesia. Patients will be randomly assigned to TEAS group and control group. After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. In other words, the patients will receive TEAS stimulation for 30min, then no stimulation for 30min, then stimulation for another 30min, etc, until the end of the surgery. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.
- Conditions
- Post-operative Cognitive Dysfunction
- Being tested
- Transcutaneous electrical acupoint stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationProcedure or surgery
TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | Patients in the TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. The stimulation will repeat until the end of surgery. Receives: Procedure: Transcutaneous electrical acupoint stimulation |
| control group | No intervention | In patients from the control group, the electrodes will only be attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of POCD
cognitive function of the patients will be analyzed with MMSE, Digital breadth, Number symbol, Visual regeneration, Color word conversion, Color Trail Marking Test (PartB) and CAM, and reflected by Z score with the following formula: Z=（Xafter-Xbefore）/SDbefore
Measured: at Day 7 post-surgery
Secondary outcomes (6)
the incidence of POCD
cognitive function of the patients will be analyzed with MMSE, Digital breadth, Number symbol, Visual regeneration, Color word conversion, Color Trail Marking Test (PartB) and CAM, and reflected by Z score with the following formula: Z=（Xafter-Xbefore）/SDbefore
Measured: at Day 30 post-surgery
the incidence of delirium
whether the patients develop delirium will be analyzed with CAM
Measured: from Day 1 to Day 7 post-surgery
serum IL-1β level
an inflammatory mediator that reflects systemic inflammation
Measured: at Day 1 post-surgery
serum IL-6 level
an inflammatory mediator that reflects systemic inflammation
Measured: at Day 1 post-surgery
serum TNF-α level
an inflammatory mediator that reflects systemic inflammation
Measured: at Day 1 post-surgery
serum MMP9 level
an inflammatory mediator that reflects systemic inflammation
Measured: at Day 1 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start14 Oct 2021
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Cognitive DysfunctionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
- Investigators
- Jie Tian, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338555
- Sponsor's protocol ID
- AES20200407
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutanclus Electrical Acupoint Stimulation on Postoperative Cognitive Dysfunction in Elderly Patients
- ClinicalTrials.gov ID
- NCT04338555
- Acronym / sponsor ID
- AES20200407
- Conditions
- Post-operative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 8 Apr 2020 (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.
Patients undergoing elective orthopedics, urology, and general surgery will be included and randomly allocated to TEAS group or control group . After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.
Detailed description
This study will enroll 110 patients who are older than 60 years old and will have elective orthopedics, urology, or general surgeries under general anesthesia. Patients will be randomly assigned to TEAS group and control group. After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. In other words, the patients will receive TEAS stimulation for 30min, then no stimulation for 30min, then stimulation for another 30min, etc, until the end of the surgery. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Procedure: Transcutaneous electrical acupoint stimulationPatients in the TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. The stimulation will repeat until the end of surgery. |
| control group | No intervention | –In patients from the control group, the electrodes will only be attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≧ 60 years old;
- communicate normally；
- ASA Physical Status 1-2;
- Patients will have elective orthopedics, urology or general surgeries under general anesthesia;
- With an estimated surgery time of more than 2h;
Key exclusion criteria (7 listed)
- Patients with brain diseases or history of brain diseases;
- Preoperative diagnosis of cognitive impairment by subtle mental state (MMSE) less than 24 points;
- Patients with history of neurological and psychological disorders including AD, stroke, and psychosis;
- Severe hearing or visual impairment, illiteracy;
- preoperative systolic blood pressure >190mmHg, or diastolic blood pressure >100mmHg;
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 stimulationTEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery. | Procedure or surgery | TEAS group |
Primary outcome
the incidence of POCD
Time frame: at Day 7 post-surgery
cognitive function of the patients will be analyzed with MMSE, Digital breadth, Number symbol, Visual regeneration, Color word conversion, Color Trail Marking Test (PartB) and CAM, and reflected by Z score with the following formula: Z=（Xafter-Xbefore）/SDbefore
6 secondary outcomes
the incidence of POCD
Time frame: at Day 30 post-surgery
the incidence of delirium
Time frame: from Day 1 to Day 7 post-surgery
serum IL-1β level
Time frame: at Day 1 post-surgery
serum IL-6 level
Time frame: at Day 1 post-surgery
serum TNF-α level
Time frame: at Day 1 post-surgery
serum MMP9 level
Time frame: at Day 1 post-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 3 Jul 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.
Jie Tian principal investigator
RenJi Hospital
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 Post-operative Cognitive Dysfunction, run by RenJi 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 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 3 Jul 2024. 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?
the incidence of POCD (time frame: at Day 7 post-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 3 Jul 2024.