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Analysis of the correlation between perioperative blood glucose and delirium in elderly patients with coronary artery bypass grafting and the study of acupoint intervention

Registration number：

ITMCTR2025000500

Date of Last Refreshed on：

2025-03-10

Date of Registration：

2025-03-10

Registration Status：

Prospective registration

Public title：

Analysis of the correlation between perioperative blood glucose and delirium in elderly patients with coronary artery bypass grafting and the study of acupoint intervention

English Acronym：

Scientific title：

Analysis of the correlation between perioperative blood glucose and delirium in elderly patients with coronary artery bypass grafting and the study of acupoint intervention

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Lin Yanjuan

Study leader：

Lin Yanjuan

Applicant telephone：

+86 591 8621 8336

Study leader's telephone：

+86 591 8621 8336

Applicant Fax：

Study leader's fax：

Applicant E-mail：

fjxhyjl@163.com

Study leader's E-mail：

fjxhyjl@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

29 Xinquan Road Gulou District Fuzhou Fujian

Study leader's address：

29 Xinquan Road Gulou District Fuzhou Fujian

Applicant postcode：

350001

Study leader's postcode：

350001

Applicant's institution：

Fujian Medical University Union Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2025KY024

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics committee of Fujian Medical University Union Hospital

Date of approved by ethic committee：

2025/2/7 0:00:00

Contact Name of the ethic committee：

Xiaoyu Lai

Contact Address of the ethic committee：

29 Xinquan Road Gulou District Fuzhou Fujian

Contact phone of the ethic committee：

+86 591 8621 8325

Contact email of the ethic committee：

xhyyllwyh@163.com

Primary sponsor：

Fujian Medical University Union Hospital

Primary sponsor's address：

29 Xinquan Road Gulou District Fuzhou Fujian

Secondary sponsor：

Country：

China

Province：

Fujian

City：

Fuzhou

Institution
hospital：

Fujian Medical University Union Hospital

Address：

29 Xinquan Road Gulou District Fuzhou Fujian

Source(s) of funding：

self-financing

Target disease：

Coronary heart disease

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

(1) To investigate the correlation between perioperative blood glucose and the occurrence of delirium in elderly CABG patients. (2) A literature study and the Delphi method were used to construct an intervention programme of transcutaneous electrical acupoint stimulation combined with auricular acupoint pressure in elderly CABG patients to verify the effect in improving blood glucose and reducing delirium.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) between 60 and 85 years of age; (2) elective coronary artery bypass grafting under extracorporeal circulation.

Exclusion criteria：

(1) have a history of mental illness or mild cognitive impairment (score <3 using Mini-Cog screening); (2) have a history of alcoholism or history of substance abuse; (3) have severe vision hearing and speech impairments; (4) require long-term use of hormonal medications; (5) contraindications to transcutaneous electrical acupoint stimulation or auricular acupressure: e.g. pacemaker skin infection auricular skin damage allergy to polar tablets etc.; (6) the existence of severe liver and kidney dysfunction before the operation; (7) the existence of obvious blood sugar abnormalities before the operation such as HbA1c ≥ 6.5%; (8) the number of days between confirmation of surgery and the day of surgery is less than 3 days; (9) already participating in other clinical trials.

Study execute time：

From 2025-02-08

To      2025-12-30

Recruiting time：

From 2025-04-01

To      2025-07-01

Interventions：

35

Group：

Experimental group

Sample size：

Intervention：

Transcutaneous electrical acupoint stimulation combined with auricular acupoint pressure intervention programme on the basis of routine blood glucose management in the control group

Intervention code：

35

Group：

Control group

Sample size：

Intervention：

Implementation of a routine blood glucose management programme

Intervention code：

Total sample size ： 70

Countries of recruitment
and research settings：

Country：

China

Province：

Fujian

City：

Fuzhou

Institution/hospital：

Fujian Medical University Union Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Blood glucose 1 day before surgery

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Intensive Care Unit Hospitalization Days

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Duration of mechanical ventilation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of delirium at 7 days postoperatively

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Dosage of postoperative insulin

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Neutrophil to lymphocyte ratio on the first postoperative day

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence of abnormal blood glucose values at 3 days postoperatively

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

postoperative pain

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

C-reactive protein level on the first postoperative day

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Coefficient of variation of blood glucose at 3 days postoperatively

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

postoperative anxiety

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

N/A

Tissue：

Fate of sample 

Others

Note：

Not yet 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)：

This study used block group randomisation whereby random sequences were generated by a research assistant independent of the research team using SAS 9.4 software. The process of generating the random sequence followed a 1:1 allocation ratio (control group to test group). The generated random sequences were stored in an encrypted electronic file in the possession of the research assistant only which was inaccessible to the research team throughout the study.

Blinding：

This study blinded the data analyser.

IPD sharing：

No

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

December 31, 2026, Clinical Trial Public Management Platform, http://www.medresman.org.cn

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

Fujian heart Medical center medical record system

Data Managemen Committee：

Not yet

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

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