Pharmacogenetics Study on the Effects of Anesthetic Drugs on Circulatory Function

February 27, 2022 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from department of thoracic and cardiovascular surgery in Xiangya Hospital, Central South University

Description

Inclusion Criteria:

  • Undergoing general anesthesia
  • Undergoing Cardiovascular surgery

Exclusion Criteria:

  • ASA granding more than five
  • Severe organ dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotyping results of anesthetic drugs
Time Frame: one year
Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital signs
Time Frame: one year
The percentage of change in mean arterial pressure and heart rate
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
depth of anesthesia
Time Frame: one year
The value of BIS
one year
prognostic indicator
Time Frame: one year
The days of patients' hospital stay time
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

February 10, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 27, 2022

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYHMZK PG 2000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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