Drug ReactionNCT03839186
Pharmacogenetics Study on the Effects of Anesthetic Drugs on Circulatory Function
An observational study of Drug Reaction and Anesthetic, run by Xiangya Hospital of Central South University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Drug Reaction, Anesthetic, Hemodynamic Rebound
- How many people
- 223 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from department of thoracic and cardiovascular surgery in Xiangya Hospital, Central South University
Who may be able to join
- Undergoing general anesthesia
- Undergoing Cardiovascular surgery
Who cannot join
- ASA granding more than five
- Severe organ dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
About this study
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
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.
Read the 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.
- Conditions
- Drug Reaction, Anesthetic, Hemodynamic Rebound, Gene
- Keywords
- personalized medicine, genetic polymorphism, pharmacogenetics, hemodynamic change
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotyping results of anesthetic drugs
Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG
Measured: one year
Secondary outcomes (1)
vital signs
The percentage of change in mean arterial pressure and heart rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startAug 2016
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ReactionStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- e wang, doctor, Study chair, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839186
- Sponsor's protocol ID
- XYHMZK PG 2000
- Status last verified
- Mar 2018
- First submitted
- 13 Dec 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03839186
- Acronym / sponsor ID
- XYHMZK PG 2000
- Conditions
- Drug Reaction, Anesthetic, Hemodynamic Rebound, Gene
- Keywords
- personalized medicine, genetic polymorphism, pharmacogenetics, hemodynamic change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from department of thoracic and cardiovascular surgery in Xiangya Hospital, Central South University
Key inclusion criteria (2 listed)
- Undergoing general anesthesia
- Undergoing Cardiovascular surgery
Key exclusion criteria (2 listed)
- ASA granding more than five
- Severe organ dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genotyping results of anesthetic drugs
Time frame: one year
Genotype information of SNP related to anesthetic drug metabolism, such as AA, AG or GG
1 secondary outcome
vital signs
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
e wang, doctor study chair
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Reaction and Anesthetic, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotyping results of anesthetic drugs (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.