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Effect of transcutaneous electrical acupoint stimulation on incidence of hypotension during anesthesia induction in laparoscopic rectal cancer resection

Registration number：

ITMCTR2025000108

Date of Last Refreshed on：

2025-01-14

Date of Registration：

2025-01-14

Registration Status：

Prospective registration

Public title：

Effect of transcutaneous electrical acupoint stimulation on incidence of hypotension during anesthesia induction in laparoscopic rectal cancer resection

English Acronym：

Scientific title：

Application of transcutaneous acupoint electrical stimulation in stabilizing hemodynamics during laparoscopic resection of colorectal cancer

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Meng Song

Study leader：

Wang Mingyu

Applicant telephone：

15131848461

Study leader's telephone：

17332930192

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1572119831@qq.com

Study leader's E-mail：

3377038708@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Zhonghai Heping Phase III Heping District Shenyang City Liaoning Province China 29-3-21-1

Study leader's address：

No. 44 Xiaohe Road Wanquan Street Dadong District Shenyang City Liaoning Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Liaoning Cancer Hospital

Approved by ethic committee：

Approved No. of ethic committee：

KT20240308

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Liaoning Cancer Hospital

Date of approved by ethic committee：

2024/3/6 0:00:00

Contact Name of the ethic committee：

Liu Haozhe

Contact Address of the ethic committee：

No. 44 Xiaohe Road Wanquan Street Dadong District Shenyang City Liaoning Province

Contact phone of the ethic committee：

02431916632

Contact email of the ethic committee：

szlyy315@163.com

Primary sponsor：

Liaoning Cancer Hospital

Primary sponsor's address：

No. 44 Xiaohe Road Wanquan Street Dadong District Shenyang City Liaoning Province

Secondary sponsor：

Country：

China

Province：

LiaoNing

City：

ShenYang

Institution
hospital：

Liaoning Cancer Hospital

Address：

No. 44 Xiaohe Road Wanquan Street Dadong District Shenyang City Liaoning Province

Source(s) of funding：

Liaoning Cancer Hospital

Target disease：

The effect of transcutaneous acupoint electrical stimulation on hypotension

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

By observing the changes in hemodynamics during laparoscopic surgery for colorectal cancer this study explores the impact of percutaneous electrical acupoint stimulation therapy on hemodynamics.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Patients admitted to Liaoning Cancer Hospital who plan to undergo laparoscopic resection of colorectal cancer; 2. ASA classification is level II-III; 3. Age ranges from 40 to 65 years old.

Exclusion criteria：

1. Skin injuries rashes or local infections intended for use in electrical stimulation sites or the presence of metal implants near the site; 2. Implant pacemakers pacemakers or defibrillators; 3. Implant electronic insulin pumps or other types of electronic implantable devices; 4. Pregnant or breastfeeding period; 5. Central nervous system diseases or mental illnesses; Received electrical stimulation therapy within one week.

Study execute time：

From 2025-01-21

To      2025-03-05

Recruiting time：

From 2025-01-21

To      2025-03-05

Interventions：

52

Group：

Control Group

Sample size：

Intervention：

Only the electrodes were attached 30 min before anesthesia and electrical stimulation was not initiated.

Intervention code：

52

Group：

TEAS Group

Sample size：

Intervention：

Transcutaneous acupoint electrical stimulation for 30 minutes before anesthesia

Intervention code：

Total sample size ： 104

Countries of recruitment
and research settings：

Country：

China

Province：

LiaoNing

City：

ShenYang

Institution/hospital：

Liaoning Cancer Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Blood pressure heart rate during pneumoperitoneum

Type：

Secondary indicator

Measure time point of outcome：

during pneumoperitoneum

Measure method：

Cuffs

Outcome：

Blood gas analysis in PACU

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure heart rate on entering the operating room

Type：

Secondary indicator

Measure time point of outcome：

entering the operating room

Measure method：

Cuffs

Outcome：

Incidence of hypotension during induction of anesthesia

Type：

Primary indicator

Measure time point of outcome：

From the beginning of anesthesia induction to 5 minutes after pneumoperitoneum establishment

Measure method：

Cuffs

Outcome：

Blood pressure and heart rate 5 min after pneumoperitoneum

Type：

Secondary indicator

Measure time point of outcome：

5 min after pneumoperitoneum

Measure method：

Cuffs

Outcome：

VAS score after extubation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure and heart rate 5 min after intubation

Type：

Secondary indicator

Measure time point of outcome：

5 minutes after intubation

Measure method：

Cuffs

Outcome：

Blood pressure and heart rate at PACU entry

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Extubation time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS score at Pacu exit

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure and heart rate during skin incision

Type：

Secondary indicator

Measure time point of outcome：

When cutting skin

Measure method：

Cuffs

Outcome：

Use of vasoactive drugs

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood gas analysis before operation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Preoperative blood pressure

Type：

Secondary indicator

Measure time point of outcome：

The day before the operation

Measure method：

Cuffs

Outcome：

Incidence of nausea and vomiting

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Recovery rate of analgesics

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure and heart rate during extubation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure and heart rate during intubation

Type：

Secondary indicator

Measure time point of outcome：

Intubating

Measure method：

Cuffs

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

40
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Randomly group using SPSS 25.0 software. The research subjects were numbered one by one according to the order of enrollment using the Rv function in the SPSS random number generator Generate random numbers using the Uniform function and then group them using SPSS Visual Binning functionality. As this study is a randomized controlled trial divided into two groups the patients were randomly assigned to Group 1 and Group 2.Regarding blinding the grouping results of each subject are written in an opaque and sealed envelope with the subject's chronological number on the outside and handed over to the TEAS operator. This random process was completed by a person who did not participate in the study. After the patient enters the preoperative preparation room TEAS operators perform TEAS operations based on the contents of the envelope. If the envelope contains "1" use a acupoint nerve stimulator to treat for 30 minutes. If the envelope contains "2" perform sham stimulation (only connected to the electrode without ini

Blinding：

IPD sharing：

No

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

https://www.cmu.edu.cn/cmuyjs/

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

All data obtained are entered into a computerized SPSS 23.0 and all data do not show personal information of the patient and the parts involving names case numbers and other private information are replaced by numbers.

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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