AnesthesiaNCT04047329
Risk Factors and Impact of Anesthesia Techniques on Myocardial Infarction Following Transurethral Resection of the Prostate
An observational study of Anesthesia and Transurethral Resection of Prostate Syndrome, run by Chang Gung Memorial Hospital.
Trial summary
This study examined the risk factors and the influence of the type of anesthetic used during transurethral resection of the prostate (TURP) on subsequent incidence of myocardial infarction (MI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Transurethral Resection of Prostate Syndrome, Myocardial Infarction
- What is being tested?
- general anesthesia or neuraxial anesthesia
- How many people
- 115,025 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1998to 22 Mar 2016
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients receiving TURP
Who may be able to join
- Patients receiving TURP surgery (1998-2012)
Who cannot join
- Patients without anesthesia records
- Patients receiving both general and neuraxial anesthesia
- Mortality within 12 months of TURP
About this study
Official title: Risk Factors and Impact of Anesthesia Techniques on Myocardial Infarction Following Transurethral Resection of the Prostate: a Nationwide Database Case Control Study
This study examined the risk factors and the influence of the type of anesthetic used during transurethral resection of the prostate (TURP) on subsequent incidence of myocardial infarction (MI).
Read the detailed description
This study utilized a population-based, nationwide dataset to evaluate the risk factors of MI for patients with benign prostate hypertrophy (BPH) who received TURP. Besides, The study also compared the different effects of general anesthesia (GA) and neuraxial anesthesia (NA) on the incidence of MI within 6 and 12 months after TURP.
- Being tested
- general anesthesia or neuraxial anesthesia
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia or neuraxial anesthesiaOther
| Study group | Role | What they receive |
|---|---|---|
| Without post-operative myocardial infarction | Patients without post-operative myocardial infarction after first admission for transurethral resection of the prostate Receives: Other: general anesthesia or neuraxial anesthesia | |
| With post-operative myocardial infarction | Patients with post-operative myocardial infarction after first admission for transurethral resection of the prostate Receives: Other: general anesthesia or neuraxial anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative myocardial infarction
Patients experienced myocardial infarction after transurethral resection of the prostate (TURP)
Measured: within 6 months after the first admission for TURP
Postoperative myocardial infarction
Patients experienced myocardial infarction after transurethral resection of the prostate (TURP)
Measured: within 12 months after the first admission for TURP
Patient's age (year-old) that developed post-TURP myocardial infarction
We analyze age distribution of patients with post-TURP myocardial infarction
Measured: within 6 months after the first admission for TURP
Patient's age (year-old) that developed post-TURP myocardial infarction
We analyze age distribution of patients with post-TURP myocardial infarction
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed Diabetes Mellitus developing post-TURP myocardial infarction
We analyze pre-operative diagnosed Diabetes Mellitus rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed Diabetes Mellitus developing post-TURP myocardial infarction
We analyze pre-operative diagnosed Diabetes Mellitus rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed disorders of lipoid metabolism developing post-TURP myocardial infarction
We analyze pre-operative diagnosed disorders of lipoid metabolism rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed disorders of lipoid metabolism developing post-TURP myocardial infarction
We analyze pre-operative diagnosed disorders of lipoid metabolism rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed gout developing post-TURP myocardial infarction
We analyze pre-operative diagnosed gout rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed gout developing post-TURP myocardial infarction
We analyze pre-operative diagnosed gout rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed hypertension developing post-TURP myocardial infarction
We analyze pre-operative diagnosed hypertension rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed hypertension developing post-TURP myocardial infarction
We analyze pre-operative diagnosed hypertension rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed heart disease history developing post-TURP myocardial infarction
We analyze pre-operative diagnosed heart disease rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed heart disease history developing post-TURP myocardial infarction
We analyze pre-operative diagnosed heart disease rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed stroke history developing post-TURP myocardial infarction
We analyze pre-operative diagnosed stroke rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed stroke history developing post-TURP myocardial infarction
We analyze pre-operative diagnosed stroke rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed liver cirrhosis history developing post-TURP myocardial infarction
We analyze pre-operative diagnosed liver cirrhosis rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed liver cirrhosis history developing post-TURP myocardial infarction
We analyze pre-operative diagnosed liver cirrhosis rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed chronic obstructive pulmonary disease developing post-TURP myocardial infarction
We analyze pre-operative diagnosed chronic obstructive pulmonary disease rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed chronic obstructive pulmonary disease developing post-TURP myocardial infarction
We analyze pre-operative diagnosed chronic obstructive pulmonary disease rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Number of patients with pre-operative diagnosed asthma developing post-TURP myocardial infarction
We analyze pre-operative diagnosed asthma rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 6 months after the first admission for TURP
Number of patients with pre-operative diagnosed asthma developing post-TURP myocardial infarction
We analyze pre-operative diagnosed asthma rate in patients who had myocardial infarction after the surgery of TURP.
Measured: within 12 months after the first admission for TURP
Secondary outcomes (4)
Number of patients who had post-operative myocardial infarction after receiving general anesthesia for TURP
Number of patients who had post-operative myocardial infarction after receiving general anesthesia for TURP
Measured: within 6 months after the first admission for TURP
Number of patients who had post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Number of patients who had post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Measured: within 6 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving general anesthesia for TURP
Number of patients who did not have post-operative myocardial infarction after receiving general anesthesia for TURP
Measured: within 12 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Number of patients who did not have post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Measured: within 12 months after the first admission for TURP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jan 1998
- Primary completion31 Dec 2012
- Study completion22 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 115,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047329
- Sponsor's protocol ID
- 104-6697B
- Status last verified
- Sep 2015
- First submitted
- 23 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Impact of Anesthesia Techniques on Myocardial Infarction Following Transurethral Resection of the Prostate: a Nationwide Database Case Control Study
- ClinicalTrials.gov ID
- NCT04047329
- Acronym / sponsor ID
- 104-6697B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115,025 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 22 Mar 2016 (actual)
- First posted
- 6 Aug 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 examined the risk factors and the influence of the type of anesthetic used during transurethral resection of the prostate (TURP) on subsequent incidence of myocardial infarction (MI).
Detailed description
This study utilized a population-based, nationwide dataset to evaluate the risk factors of MI for patients with benign prostate hypertrophy (BPH) who received TURP. Besides, The study also compared the different effects of general anesthesia (GA) and neuraxial anesthesia (NA) on the incidence of MI within 6 and 12 months after TURP.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without post-operative myocardial infarction | – | Other: general anesthesia or neuraxial anesthesiaPatients without post-operative myocardial infarction after first admission for transurethral resection of the prostate |
| With post-operative myocardial infarction | – | Other: general anesthesia or neuraxial anesthesiaPatients with post-operative myocardial infarction after first admission for transurethral resection of the prostate |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving TURP
Key inclusion criteria (1 listed)
- Patients receiving TURP surgery (1998-2012)
Key exclusion criteria (3 listed)
- Patients without anesthesia records
- Patients receiving both general and neuraxial anesthesia
- Mortality within 12 months of TURP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesia or neuraxial anesthesia | Other | With post-operative myocardial infarction, Without post-operative myocardial infarction |
Primary outcome
Postoperative myocardial infarction
Time frame: within 6 months after the first admission for TURP
Patients experienced myocardial infarction after transurethral resection of the prostate (TURP)
Postoperative myocardial infarction
Time frame: within 12 months after the first admission for TURP
Patients experienced myocardial infarction after transurethral resection of the prostate (TURP)
Patient's age (year-old) that developed post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze age distribution of patients with post-TURP myocardial infarction
Patient's age (year-old) that developed post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze age distribution of patients with post-TURP myocardial infarction
Number of patients with pre-operative diagnosed Diabetes Mellitus developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed Diabetes Mellitus rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed Diabetes Mellitus developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed Diabetes Mellitus rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed disorders of lipoid metabolism developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed disorders of lipoid metabolism rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed disorders of lipoid metabolism developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed disorders of lipoid metabolism rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed gout developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed gout rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed gout developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed gout rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed hypertension developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed hypertension rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed hypertension developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed hypertension rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed heart disease history developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed heart disease rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed heart disease history developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed heart disease rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed stroke history developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed stroke rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed stroke history developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed stroke rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed liver cirrhosis history developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed liver cirrhosis rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed liver cirrhosis history developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed liver cirrhosis rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed chronic obstructive pulmonary disease developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed chronic obstructive pulmonary disease rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed chronic obstructive pulmonary disease developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed chronic obstructive pulmonary disease rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed asthma developing post-TURP myocardial infarction
Time frame: within 6 months after the first admission for TURP
We analyze pre-operative diagnosed asthma rate in patients who had myocardial infarction after the surgery of TURP.
Number of patients with pre-operative diagnosed asthma developing post-TURP myocardial infarction
Time frame: within 12 months after the first admission for TURP
We analyze pre-operative diagnosed asthma rate in patients who had myocardial infarction after the surgery of TURP.
4 secondary outcomes
Number of patients who had post-operative myocardial infarction after receiving general anesthesia for TURP
Time frame: within 6 months after the first admission for TURP
Number of patients who had post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Time frame: within 6 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving general anesthesia for TURP
Time frame: within 12 months after the first admission for TURP
Number of patients who did not have post-operative myocardial infarction after receiving neuraxial anesthesia for TURP
Time frame: within 12 months after the first admission for TURP
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 7 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Transurethral Resection of Prostate Syndrome, run by Chang Gung Memorial Hospital.
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 1 inclusion and 3 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative myocardial infarction (time frame: within 6 months after the first admission for TURP). The study lists 22 primary outcomes in all. 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 7 Aug 2019.