Postoperative Cognitive DysfunctionNCT04606888
Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction
A study testing Transcutaneous electrical acupoint stimulation in people with Postoperative Cognitive Dysfunction, run by Subei People's Hospital of Jiangsu Province at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) is one of the common complications of cancer patients after operation with a 8.9%-46.1% incidence, which severely affecting patients' postoperative recovery, increasing the medical cost, affecting the social function of patients, reducing the quality of life and increasing… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- 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
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Sep 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 60 years or older;
- Patients were diagnosed with gastrointestinal tumor and received radical; resection of gastrointestinal tumors under general anesthesia in Subei people's hospital of Jiangsu province;
- The patients understood the research content and signed the informed consent form;
- American Society of Anesthesiology (ASA) score I-III;
- No frailty before operation;
- D-dimer was normal before the operation
Who cannot join
- Patients with cognitive dysfunction before the operation or patients with previous history of cognitive dysfunction, dementia and delirium;
- Patients with a history of severe depression, schizophrenia and other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past;
- Patients with severe hearing or visual impairment due to eye or ear diseases without assistive tools;
- Patients who are unable to communicate or have difficulty communicating;
- According to the definition of "China chronic disease and its risk factors monitoring report (2010)" (male average daily pure alcohol intake ≥ 61g, female average daily pure alcohol intake ≥ 41g, alcohol volume (g) = alcohol consumption (ML) × alcohol content% × 0.8);
- Patients who were hospitalized for three months or more before surgery or who had received surgical treatment within three months;
Show all 14Show fewer
- Patients who can't take care of themselves or are physically disabled and unable to carry out nerve function test;
- Patients with severe heart, liver and renal failure;
- Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 minutes during operation;
- Patients admitted to ICU after operation;
- Patients who quit or died due to noncooperation or sudden situation;
- Patients who already participate in other clinical studies which may influence this study;
- Patient who underwent emergency surgery;
- Patient had a history of recent or conventional acupuncture treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction in Geriatric Patients With Gastrointestinal Tumor
Postoperative cognitive dysfunction (POCD) is one of the common complications of cancer patients after operation with a 8.9%-46.1% incidence, which severely affecting patients' postoperative recovery, increasing the medical cost, affecting the social function of patients, reducing the quality of life and increasing the mortality.
Surgical trauma and perioperative pain can induce systematic inflammatory response and release systematic inflammatory mediators, which can enter the central nervous system (CNS) and lead to CNS inflammatory. In order to prevent the development of POCD among elder patients, the discovery of effective interventions reducing perioperative pain and inflammatory response is important.
Read more
Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive alternative to needle-based electro-acupuncture (EA). It combines the acupuncture and transcutaneous electrical nerve stimulation (TENS) by pasting the electrode piece on the acupoint instead of sticking the needles on the skin. TEAS can trigger the release of endogenous neurotransmitters, releasing endogenous analgesic substances, such as endorphins. TEAS also can reduce the intraoperative anesthetic consumption, postoperative pain score, postoperative nausea and vomiting (PONV), and improve the postoperative recovery of patients. Recently, TEAS was found to improve the cognitive function of geriatric patients with silent lacunar infarction. However, the current TEAS mainly focus on intraoperative. The effect of perioperative TEAS on POCD is not clear.
Here, the effect of TEAS on POCD in geriatric adults undergoing radical resection of gastrointestinal tumors under general anesthesia was investigated to determine whether TEAS can decrease perioperative pain or inflammatory response to prevent the occurrence of POCD and to find out the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.
Read the detailed description
This study aims to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in elderly patients who were diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia and to determine the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Transcutaneous electrical acupoint stimulation
- Keywords
- POCD, TEAS, Gastrointestinal tumor
- Medical subject headings
- Postoperative Cognitive Complications, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationDevice
According to the traditional Chinese medicine 15,three acupuncture points were selected as the target points: bilateral Neiguan ,Yintang and bilateral Zusanli.. A transcutaneous electrical stimulator was used to provide an altered frequency 2/100 Hz,disperse-dense waves,and adjusted intensity which was less than 10mA.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical acupoint stimulation group | Experimental | Transcutaneous electrical acupoint stimulation group patients received Transcutaneous electrical acupoint stimulation (Neiguan [PC6], Yintang [GV 29], Zusanli [ST36]) for 30 min before the induction of anaesthesia until the end of the surgery and the night before operation, the first, second and third night after operation 30 min once a day with an altered frequency 2/100 Hz, disperse-dense waves, adjusted electricity intensity which was less than 10 mA. Receives: Device: Transcutaneous electrical acupoint stimulation |
| Control group | No intervention | In Control group, except the electronic stimulation was not applied, the treatment was the same as the Transcutaneous electrical acupoint stimulation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination score
Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.
Measured: In the morning of the day before operation
Mini-Mental State Examination score
Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.
Measured: Three days after operation
C reactive protein
Assess the inflammatory reaction of the patient
Measured: The day before operation.
C reactive protein
Assess the inflammatory reaction of the patient
Measured: The 1st day after the operation.
C reactive protein
Assess the inflammatory reaction of the patient
Measured: The 3rd day after the operation.
Interleukin-6
Assess the inflammatory reaction of the patient
Measured: The day before operation.
Interleukin-6
Assess the inflammatory reaction of the patient
Measured: The 1st day after the operation.
Interleukin-6
Assess the inflammatory reaction of the patient
Measured: The 3rd day after the operation.
S100 calcium-binding protein β
Assess the inflammatory reaction of the patient
Measured: The day before operation.
S100 calcium-binding protein β
Assess the inflammatory reaction of the patient
Measured: The 1st day after the operation.
S100 calcium-binding protein β
Assess the inflammatory reaction of the patient
Measured: The 3rd day after the operation.
Secondary outcomes (5)
Numeric Rating Scale score
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Measured: The day before operation
Numeric Rating Scale score
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Measured: The day of operation
Numeric Rating Scale score
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Measured: The 1st day after the operation.
Numeric Rating Scale score
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Measured: The 2rd day after the operation.
Numeric Rating Scale score
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Measured: The 3nd day after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Transcutaneous electrical acupoint stimulation group and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Subei People's Hospital of Jiangsu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijuan Xi, Subei People's Hospital of Jiangsu Province
- Investigators
- Daorong Wang, Ph.D., Principal investigator, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606888
- Sponsor's protocol ID
- LijuanXi
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Underlie results in a publication
Publications
Correction: Influence of postoperative analgesia on systemic inflammatory response and postoperative cognitive dysfunction after femoral fractures surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Oct;44(10):e2. doi: 10.1136/rapm-2018-000023corr1. No abstract available.
PubMed 31534004Li Y, Huang D, Su D, Chen J, Yang L. Postoperative cognitive dysfunction after robot-assisted radical cystectomy (RARC) with cerebral oxygen monitoring an observational prospective cohort pilot study. BMC Anesthesiol. 2019 Nov 6;19(1):202. doi: 10.1186/s12871-019-0877-5.
PubMed 31694553Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
PubMed 12648190Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.
PubMed 29889707Borges J, Moreira J, Moreira A, Santos A, Abelha FJ. [Impact of postoperative cognitive decline in quality of life: a prospective study]. Rev Bras Anestesiol. 2017 Jul-Aug;67(4):362-369. doi: 10.1016/j.bjan.2016.07.007. Epub 2017 Apr 12. Portuguese.
PubMed 28412051Kotekar N, Shenkar A, Nagaraj R. Postoperative cognitive dysfunction - current preventive strategies. Clin Interv Aging. 2018 Nov 8;13:2267-2273. doi: 10.2147/CIA.S133896. eCollection 2018.
PubMed 30519008Huang JM, Lv ZT, Zhang B, Jiang WX, Nie MB. Intravenous parecoxib for early postoperative cognitive dysfunction in elderly patients: evidence from a meta-analysis. Expert Rev Clin Pharmacol. 2020 Apr;13(4):451-460. doi: 10.1080/17512433.2020.1732815. Epub 2020 Feb 28.
PubMed 32077347Yang W, Kong LS, Zhu XX, Wang RX, Liu Y, Chen LR. Effect of dexmedetomidine on postoperative cognitive dysfunction and inflammation in patients after general anaesthesia: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(18):e15383. doi: 10.1097/MD.0000000000015383.
PubMed 31045788Lv ZT, Huang JM, Zhang JM, Zhang JM, Guo JF, Chen AM. Effect of Ulinastatin in the Treatment of Postperative Cognitive Dysfunction: Review of Current Literature. Biomed Res Int. 2016;2016:2571080. doi: 10.1155/2016/2571080. Epub 2016 Aug 14.
PubMed 27597957Deng LQ, Hou LN, Song FX, Zhu HY, Zhao HY, Chen G, Li JJ. Effect of pre-emptive analgesia by continuous femoral nerve block on early postoperative cognitive function following total knee arthroplasty in elderly patients. Exp Ther Med. 2017 Apr;13(4):1592-1597. doi: 10.3892/etm.2017.4099. Epub 2017 Feb 3.
PubMed 28413514Zhang Q, Gao Z, Wang H, Ma L, Guo F, Zhong H, Xiong L, Wang Q. The effect of pre-treatment with transcutaneous electrical acupoint stimulation on the quality of recovery after ambulatory breast surgery: a prospective, randomised controlled trial. Anaesthesia. 2014 Aug;69(8):832-9. doi: 10.1111/anae.12639. Epub 2014 May 28.
PubMed 24865978Gao F, Zhang Q, Li Y, Tai Y, Xin X, Wang X, Wang Q. Transcutaneous electrical acupoint stimulation for prevention of postoperative delirium in geriatric patients with silent lacunar infarction: a preliminary study. Clin Interv Aging. 2018 Oct 24;13:2127-2134. doi: 10.2147/CIA.S183698. eCollection 2018.
PubMed 30425466Xi L, Fang F, Yuan H, Wang D. Transcutaneous electrical acupoint stimulation for postoperative cognitive dysfunction in geriatric patients with gastrointestinal tumor: a randomized controlled trial. Trials. 2021 Aug 23;22(1):563. doi: 10.1186/s13063-021-05534-9.
PubMed 34425851
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction in Geriatric Patients With Gastrointestinal Tumor
- ClinicalTrials.gov ID
- NCT04606888
- Acronym / sponsor ID
- LijuanXi
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- POCD, TEAS, Gastrointestinal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Subei People's Hospital of Jiangsu ProvinceUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 28 Oct 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.
Postoperative cognitive dysfunction (POCD) is one of the common complications of cancer patients after operation with a 8.9%-46.1% incidence, which severely affecting patients' postoperative recovery, increasing the medical cost, affecting the social function of patients, reducing the quality of life and increasing the mortality.
Surgical trauma and perioperative pain can induce systematic inflammatory response and release systematic inflammatory mediators, which can enter the central nervous system (CNS) and lead to CNS inflammatory. In order to prevent the development of POCD among elder patients, the discovery of effective interventions reducing perioperative pain and inflammatory response is important.
Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive alternative to needle-based electro-acupuncture (EA). It combines the acupuncture and transcutaneous electrical nerve stimulation (TENS) by pasting the electrode piece on the acupoint instead of sticking the needles on the skin. TEAS can trigger the release of endogenous neurotransmitters, releasing endogenous analgesic substances, such as endorphins. TEAS also can reduce the intraoperative anesthetic consumption, postoperative pain score, postoperative nausea and vomiting (PONV), and improve the postoperative recovery of patients. Recently, TEAS was found to improve the cognitive function of geriatric patients with silent lacunar infarction. However, the current TEAS mainly focus on intraoperative. The effect of perioperative TEAS on POCD is not clear.
Here, the effect of TEAS on POCD in geriatric adults undergoing radical resection of gastrointestinal tumors under general anesthesia was investigated to determine whether TEAS can decrease perioperative pain or inflammatory response to prevent the occurrence of POCD and to find out the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.
Detailed description
This study aims to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in elderly patients who were diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia and to determine the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Transcutaneous electrical acupoint stimulation group and control group
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical acupoint stimulation group | Experimental | Device: Transcutaneous electrical acupoint stimulationTranscutaneous electrical acupoint stimulation group patients received Transcutaneous electrical acupoint stimulation (Neiguan [PC6], Yintang [GV 29], Zusanli [ST36]) for 30 min before the induction of anaesthesia until the end of the surgery and the night before operation, the first, second and third night after operation 30 min once a day with an altered frequency 2/100 Hz, disperse-dense waves, adjusted electricity intensity which was less than 10 mA. |
| Control group | No intervention | –In Control group, except the electronic stimulation was not applied, the treatment was the same as the Transcutaneous electrical acupoint stimulation group. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 60 years or older;
- Patients were diagnosed with gastrointestinal tumor and received radical; resection of gastrointestinal tumors under general anesthesia in Subei people's hospital of Jiangsu province;
- The patients understood the research content and signed the informed consent form;
- American Society of Anesthesiology (ASA) score I-III;
- No frailty before operation;
Key exclusion criteria (14 listed)
- Patients with cognitive dysfunction before the operation or patients with previous history of cognitive dysfunction, dementia and delirium;
- Patients with a history of severe depression, schizophrenia and other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past;
- Patients with severe hearing or visual impairment due to eye or ear diseases without assistive tools;
- Patients who are unable to communicate or have difficulty communicating;
- According to the definition of "China chronic disease and its risk factors monitoring report (2010)" (male average daily pure alcohol intake ≥ 61g, female average daily pure alcohol intake ≥ 41g, alcohol volume (g) = alcohol consumption (ML) × alcohol content% × 0.8);
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 stimulationAccording to the traditional Chinese medicine 15,three acupuncture points were selected as the target points: bilateral Neiguan ,Yintang and bilateral Zusanli.. A transcutaneous electrical stimulator was used to provide an altered frequency 2/100 Hz,disperse-dense waves,and adjusted intensity which was less than 10mA. | Device | Transcutaneous electrical acupoint stimulation group |
Primary outcome
Mini-Mental State Examination score
Time frame: In the morning of the day before operation
Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.
Mini-Mental State Examination score
Time frame: Three days after operation
Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.
C reactive protein
Time frame: The day before operation.
Assess the inflammatory reaction of the patient
C reactive protein
Time frame: The 1st day after the operation.
Assess the inflammatory reaction of the patient
C reactive protein
Time frame: The 3rd day after the operation.
Assess the inflammatory reaction of the patient
Interleukin-6
Time frame: The day before operation.
Assess the inflammatory reaction of the patient
Interleukin-6
Time frame: The 1st day after the operation.
Assess the inflammatory reaction of the patient
Interleukin-6
Time frame: The 3rd day after the operation.
Assess the inflammatory reaction of the patient
S100 calcium-binding protein β
Time frame: The day before operation.
Assess the inflammatory reaction of the patient
S100 calcium-binding protein β
Time frame: The 1st day after the operation.
Assess the inflammatory reaction of the patient
S100 calcium-binding protein β
Time frame: The 3rd day after the operation.
Assess the inflammatory reaction of the patient
5 secondary outcomes
Numeric Rating Scale score
Time frame: The day before operation
Numeric Rating Scale score
Time frame: The day of operation
Numeric Rating Scale score
Time frame: The 1st day after the operation.
Numeric Rating Scale score
Time frame: The 2rd day after the operation.
Numeric Rating Scale score
Time frame: The 3nd day after the operation.
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 29 Oct 2020.
- Background: PubMed 31534004Correction: Influence of postoperative analgesia on systemic inflammatory response and postoperative cognitive dysfunction after femoral fractures surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Oct;44(10):e2. doi: 10.1136/rapm-2018-000023corr1. No abstract available.
- Background: PubMed 31694553Li Y, Huang D, Su D, Chen J, Yang L. Postoperative cognitive dysfunction after robot-assisted radical cystectomy (RARC) with cerebral oxygen monitoring an observational prospective cohort pilot study. BMC Anesthesiol. 2019 Nov 6;19(1):202. doi: 10.1186/s12871-019-0877-5.
- Background: PubMed 12648190Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
- Background: PubMed 29889707Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.
- Background: PubMed 28412051Borges J, Moreira J, Moreira A, Santos A, Abelha FJ. [Impact of postoperative cognitive decline in quality of life: a prospective study]. Rev Bras Anestesiol. 2017 Jul-Aug;67(4):362-369. doi: 10.1016/j.bjan.2016.07.007. Epub 2017 Apr 12. Portuguese.
- Background: PubMed 30519008Kotekar N, Shenkar A, Nagaraj R. Postoperative cognitive dysfunction - current preventive strategies. Clin Interv Aging. 2018 Nov 8;13:2267-2273. doi: 10.2147/CIA.S133896. eCollection 2018.
- Background: PubMed 32077347Huang JM, Lv ZT, Zhang B, Jiang WX, Nie MB. Intravenous parecoxib for early postoperative cognitive dysfunction in elderly patients: evidence from a meta-analysis. Expert Rev Clin Pharmacol. 2020 Apr;13(4):451-460. doi: 10.1080/17512433.2020.1732815. Epub 2020 Feb 28.
- Background: PubMed 31045788Yang W, Kong LS, Zhu XX, Wang RX, Liu Y, Chen LR. Effect of dexmedetomidine on postoperative cognitive dysfunction and inflammation in patients after general anaesthesia: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(18):e15383. doi: 10.1097/MD.0000000000015383.
- Background: PubMed 27597957Lv ZT, Huang JM, Zhang JM, Zhang JM, Guo JF, Chen AM. Effect of Ulinastatin in the Treatment of Postperative Cognitive Dysfunction: Review of Current Literature. Biomed Res Int. 2016;2016:2571080. doi: 10.1155/2016/2571080. Epub 2016 Aug 14.
- Background: PubMed 28413514Deng LQ, Hou LN, Song FX, Zhu HY, Zhao HY, Chen G, Li JJ. Effect of pre-emptive analgesia by continuous femoral nerve block on early postoperative cognitive function following total knee arthroplasty in elderly patients. Exp Ther Med. 2017 Apr;13(4):1592-1597. doi: 10.3892/etm.2017.4099. Epub 2017 Feb 3.
- Background: PubMed 24865978Zhang Q, Gao Z, Wang H, Ma L, Guo F, Zhong H, Xiong L, Wang Q. The effect of pre-treatment with transcutaneous electrical acupoint stimulation on the quality of recovery after ambulatory breast surgery: a prospective, randomised controlled trial. Anaesthesia. 2014 Aug;69(8):832-9. doi: 10.1111/anae.12639. Epub 2014 May 28.
- Background: PubMed 30425466Gao F, Zhang Q, Li Y, Tai Y, Xin X, Wang X, Wang Q. Transcutaneous electrical acupoint stimulation for prevention of postoperative delirium in geriatric patients with silent lacunar infarction: a preliminary study. Clin Interv Aging. 2018 Oct 24;13:2127-2134. doi: 10.2147/CIA.S183698. eCollection 2018.
- Individual participant dataSharing planned: Yes. Underlie results in a publication
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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.
Daorong Wang, Ph.D. principal investigator
Clinical Medical College of Yangzhou 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 in people with Postoperative Cognitive Dysfunction, run by Subei People's Hospital of Jiangsu Province 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 14 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 29 Oct 2020. 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?
Mini-Mental State Examination score (time frame: In the morning of the day before operation). The study lists 11 primary outcomes in all. 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 NCT04606888, which also lists 13 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 29 Oct 2020.