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Clinical study on prevention of perioperative neurocognitive impairment by Baihui and Shenting electroacupuncture

Registration number：

ITMCTR2024000150

Date of Last Refreshed on：

2024-07-31

Date of Registration：

2024-07-31

Registration Status：

Retrospective registration

Public title：

Clinical study on prevention of perioperative neurocognitive impairment by Baihui and Shenting electroacupuncture

English Acronym：

Scientific title：

Clinical study on prevention of perioperative neurocognitive impairment by Baihui and Shenting electroacupuncture

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Wang Xiangfeng

Study leader：

Wang Xiangfeng

Applicant telephone：

+86 158 5910 5366

Study leader's telephone：

+86 158 5910 5366

Applicant Fax：

Study leader's fax：

Applicant E-mail：

11375451@qq.com

Study leader's E-mail：

11375451@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 602, 817 Road, Taijiang District, Fuzhou, Fujian, China

Study leader's address：

No. 602, 817 Road, Taijiang District, Fuzhou, Fujian, China

Applicant postcode：

350004

Study leader's postcode：

350004

Applicant's institution：

People’S Hospital Affiliated to Fujian Chinese Traditional Medicine University

Approved by ethic committee：

Approved No. of ethic committee：

2023-040-03

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Date of approved by ethic committee：

2023/12/15 0:00:00

Contact Name of the ethic committee：

Hong Yingdong

Contact Address of the ethic committee：

No. 602, 817 Road, Taijiang District, Fuzhou, Fujian, China

Contact phone of the ethic committee：

+86 591 8394 2105

Contact email of the ethic committee：

12707664@qq.com

Primary sponsor：

People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Primary sponsor's address：

No. 602, 817 Road, Taijiang District, Fuzhou, Fujian, China

Secondary sponsor：

Country：

China

Province：

fujian

City：

fuzhou

Institution
hospital：

Fujian University of Traditional Chinese Medicine

Address：

No. 1, Qiuyang Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province

Source(s) of funding：

Fujian University of Traditional Chinese Medicine Medical Technology Discipline Special Project

Target disease：

perioperative neurocognitive impairment

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To investigate whether electroacupuncture stimulation with Baihui and Shenting can reduce long-term cognitive dysfunction in elderly patients after hip surgery, and whether Baihui and Shenting can reduce the release of damaged eggs and the expression of inflammatory factors in elderly patients after hip surgery. To explore the effective biological markers for the diagnosis of PND and form a reasonable scheme for electroacupuncture treatment of PND.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

60≤ age ≤85 years; Internal fixation for hip fracture: total (half) artificial hip replacement/closed reduction intramedullary nailing internal fixation; According to the American Society of Anesthesiologists grading standards ASA II to III; The patient has a certain level of education, and the cumulative time of education is ≥1 year; The estimated operation time is more than 30 minutes. Patients participate voluntarily and sign informed consent

Exclusion criteria：

Rule out serious organic diseases; Patients who did not undergo skull repair after craniotomy; Have severe speech impairment, severe vision or hearing impairment

Study execute time：

From 2023-12-15

To      2025-05-31

Recruiting time：

From 2023-12-15

To      2025-05-31

Interventions：

30

Group：

Control group

Sample size：

Intervention：

Conventional treatment

Intervention code：

30

Group：

electroacupuncture group

Sample size：

Intervention：

Baihui and Shenting electroacupuncture

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Fujian

City：

Institution/hospital：

People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

MMSE

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

TICS-m

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

CAM-CR

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Brain injury-associated proteins

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Inflammatory factor

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

60
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The experimenter groups according to the patient's selected serial number according to the random number table.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

http://www.medresman.org.cn/uc/index.aspx

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case record

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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