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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839186
Other study ID # XYHMZK PG 2000
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 moreļ¼Œthe 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

Study Design


Related Conditions & MeSH terms


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
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