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Effect of TCM constitution typing on MAC value and cortisol of sevoflurane during induction of general anesthesia

Registration number：

ITMCTR2200006713

Date of Last Refreshed on：

2022-10-27

Date of Registration：

2022-10-27

Registration Status：

Prospective registration

Public title：

Effect of TCM constitution typing on MAC value and cortisol of sevoflurane during induction of general anesthesia

English Acronym：

Scientific title：

Effect of TCM constitution typing on MAC value and cortisol of sevoflurane during induction of general anesthesia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065066 ; ChiMCTR2200006713

Applicant：

Wang Haiyan

Study leader：

Wang Haiyan

Applicant telephone：

+86 13631493942

Study leader's telephone：

+86 13631493942

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wanghy006@163.com

Study leader's E-mail：

wanghy006@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guangdong Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

广东省中医院伦理委员会BF2021-135-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2021/8/13 0:00:00

Contact Name of the ethic committee：

Li Xiaoyan

Contact Address of the ethic committee：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Contact phone of the ethic committee：

+86 20 81887233-35943

Contact email of the ethic committee：

Primary sponsor：

Guangdong Hospital of Traditional Chinese Medicine

Primary sponsor's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

Guangdong Hospital of Traditional Chinese Medicine

Address：

111 Dade Road, Yuexiu District

Source(s) of funding：

Scientific research project of Guangdong Bureau of Traditional Chinese Medicine

Target disease：

MAC value of sevoflurane in TCM constitution typing

Target disease code：

Study type：

Interventional study

Study design：

Non randomized control

Study phase：

Others

Objectives of Study：

To preliminarily explore the effect of TCM constitution typing on SEvoflurane MAC and its possible mechanism

Description for medicine or protocol of treatment in detail：

The sequential method was used to measure the MAC value of patients with consciousness loss induced by inhalation of sevoflurane under general anesthesia. The MAC value of patients with consciousness loss induced by inhalation of sevoflurane was recorded in the room before administration (T1), the target MAC value of patients with consciousness loss after inhalation of sevoflurane was reached (T2), and the MAC value of patients with consciousness loss (T3). HR, SBP, MAP, DBP, SpO2 and NI at each time point immediately after endotracheal catheter placement (T4), and plasma cortisol (Cor) values before and after endotracheal intubation were determined to determine the MAC value of sevoflurane and plasma cortisol levels for patients with different physical conditions to achieve consciousness loss during induction of general anesthesia.

Inclusion criteria

1. Patients undergoing elective general anesthesia surgery in Guangdong Hospital of Traditional Chinese Medicine 2. ASA grade I-II, age 30-50, body mass index (BMI)20-25kg/m^2 3. No vital organ dysfunction, preoperative blood routine, heart, lung, liver, kidney function were normal and no obvious hypertension 4. No long-term use of opioids or sedative-hypnotic drugs, no history of psychiatric or neurological diseases, smoking or alcohol abuse, etc 5. No hearing impairment, no difficulty in endotracheal intubation.

Exclusion criteria：

1. Patients who are allergic to therapeutic medications 2. Pregnant or breast-feeding patients 3. Communication disorder (language barrier, mental disorder), unable to cooperate 4. Patients who are currently participating in or have participated in other clinical trials within 1 month prior to this study

Study execute time：

From 2022-11-01

To      2023-06-30

Recruiting time：

From 2022-11-01

To      2023-06-30

Interventions：

25

Group：

Yang-deficient quality group

Sample size：

Intervention：

sevoflurane

Intervention code：

25

Group：

Qi-deficient quality group

Sample size：

Intervention：

sevoflurane

Intervention code：

25

Group：

blood stasis quality group

Sample size：

Intervention：

sevoflurane

Intervention code：

25

Group：

peace quality group

Sample size：

Intervention：

sevoflurane

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

Guangdong Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

MAC value of sevoflurane

Type：

Primary indicator

Measure time point of outcome：

anesthesia induction

Measure method：

Gas monitoring

Outcome：

blood pressure、heart rate

Type：

Secondary indicator

Measure time point of outcome：

Anesthesia induction period

Measure method：

monitor

Outcome：

narcotrend index

Type：

Secondary indicator

Measure time point of outcome：

Anesthesia induction period

Measure method：

Sedation depth monitoring system

Outcome：

Plasma cortisol levels

Type：

Primary indicator

Measure time point of outcome：

Before and after anesthesia intubation

Measure method：

chemiluminescent immunoassay

Collecting sample(s)
from participants：

Sample Name：

venous blood

Tissue：

blood vessel

Fate of sample 

Destruction after use

Note：

Not yet recruiting

30
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

N/A

Blinding：

Not stated

IPD sharing：

Yes

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

Not stated

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

Not stated

Data Managemen Committee：

Yes

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

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