Pharmacogenetics Study on the Effects of Anesthetic Drugs on Circulatory Function

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT03839186

Collaborator

(none)

223

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study intends to study the effects of anesthetics on Circulatory Function Genomics and find the anesthetic effects in pharmacodynamics, pharmacokinetics, drug receptor or target DNA level differences, further guiding individual treatment in clinic, promoting the development of precision the medicine.The anesthesia medication during perioperative period is more and more accurate,reasonable and safe, so as to improve the satisfaction of the patients and their families in the perioperative period, to ensure the safety of patients.

Condition or Disease	Intervention/Treatment	Phase
Drug Reaction Anesthetic Hemodynamic Rebound Gene

Detailed Description

This study is a non traumatic and non intervention study, and will use a large sample of clinical research, the number of subjects to be enrolled in the study group are 200 cases. The basic information of the study was included in the study before the operation. During the operation, the investigators need a collection of participants's arterial blood and monitor the hemodynamic index and anesthesia depth by bispectral index(BIS) . Further more，the investigators will follow up the participants' condition after operation.Dividing the patients into different groups according to their clinical features.The relationship between vital signs and the depth of anesthesia was analyzed and compared between different groups.Blood samples collected during the operation were detected by gene test. Comparing the results of genetic testing and clinical data analysis, then the investigators will find the differences in the expression of the gene polymorphisms of anesthetic drugs in the circulating function.

Study Design

Study Type:

Observational

Actual Enrollment :

223 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

The Effects of Anesthetic Drugs on Hemodynamic Changes in Cardiac Surgury and the Assotiation Between Gene Polymorphysim and Different Heart Diseases :a Pharmacogenetics Study

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Apr 1, 2019

Outcome Measures

Primary Outcome Measures

Genotyping results of anesthetic drugs [one year]
Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG

Secondary Outcome Measures

vital signs [one year]
The percentage of change in mean arterial pressure and heart rate

Other Outcome Measures

depth of anesthesia [one year]
The value of BIS
prognostic indicator [one year]
The days of patients' hospital stay time

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergoing general anesthesia
Undergoing Cardiovascular surgery

Exclusion Criteria:

ASA granding more than five
Severe organ dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital of Central South University	Changsha	Hunan	China	410000

Sponsors and Collaborators

Xiangya Hospital of Central South University

Investigators

Study Chair: e wang, doctor, Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiangya Hospital of Central South University

ClinicalTrials.gov Identifier:

NCT03839186

Other Study ID Numbers:

XYHMZK PG 2000

First Posted:

Feb 15, 2019

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Xiangya Hospital of Central South University

personalized medicine

genetic polymorphism

pharmacogenetics

hemodynamic change

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022