Pharmacogenetics Study on the Effects of Anesthetic Drugs on Circulatory Function

Drug Reaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839186
• Other study ID #: XYHMZK PG 2000
• Status: Completed
• Start date: August 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Undergoing general anesthesia
• Undergoing Cardiovascular surgery

Exclusion Criteria:

• ASA granding more than five
• Severe organ dysfunction

Related Conditions & MeSH terms

• Anesthetic
• Drug Reaction
• Drug-Related Side Effects and Adverse Reactions
• Gene
• Hemodynamic Rebound

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	depth of anesthesia	The value of BIS	one year
Other	prognostic indicator	The days of patients' hospital stay time	one year
Primary	Genotyping results of anesthetic drugs	Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG	one year
Secondary	vital signs	The percentage of change in mean arterial pressure and heart rate	one year