HypertensionNCT02244177
Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study
An observational study of Hypertension, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2013to Dec 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those patients enrolled will be divided into three groups as follows As the treatment and choice of drugs for hypertension is complex but internation guideline-oriented. We would like to enroll enough sample size in the hypertensive groups and subgroups. 1. Normaltension group (control group) 2. Hypertension without treatment 3. Hypertension with treatment as follows (according to subject's daily routine Tx, the PI not involved into the choice and further manitence of drugs) I. Hypertension with treatment with ACEI II. Hypertension with treatment with β blocker III. Hypertension with treatment with Ca channel blocker IV. Hypertension with treatment with diuretics
Who may be able to join
- 300 eligible subjects
- No contraindication for inhalation anesthesia
- Elective surgery
- Age between 20-75 y/o
- No contraindication for postoperative morphine pain control
- Female or male
- Essential hypertension stage I and II (140<=SBP<=180; 90<=DBP<=110)
Who cannot join
- Liver disease
- Renal disease
- Those who is presumed to go to ICU after surgery
- The patients with dementia or conscious disturbance
- Pregnancy or breast feeding
- Secondary hypertension
- events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina cerebrovascular events congestive heart failure significant arrhythmia thoracic surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Yuan Yi Chia, Bachelor, 88673468183, yychia@isca.vghks.gov.tw
About this study
Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normotension group | Until 11,March, 2015, 31 cases are collected. | |
| hypertension group without treatment | Until 11,March, 2015, 60 cases are collected. | |
| hypertension group with antihypertensive treatment | (ACEI, beta-blocker, Ca blocker, Diuretics) prior to the surgery. Until 11,March, 2015, 59 cases are collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: Post-operation Day1 to Day4
Secondary outcomes (1)
Morphine consumption
Measured: Post-operation Day1 to Day4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Yi Chia, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244177
- Sponsor's protocol ID
- VGHKS-103-080
- Status last verified
- Mar 2015
- First submitted
- 10 Sep 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02244177
- Acronym / sponsor ID
- VGHKS-103-080
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 18 Sep 2014 (estimated)
- 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.
Numbers of postoperative PCA related side effects among three groups will be determined by comparing and analyzing frequency distributions. To determine whether the patients with hypertension require less post operative opiate analgesics than others, multivariate analysis with repeated measures will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. The major aim of the study is to test the hypothesis that the morphine comsumpted by the hypertension group is less than those of the normotension group. The minor aims for the study are the difference related to pain intensity, or the incidence of side effects among groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normotension group | – | –Until 11,March, 2015, 31 cases are collected. |
| hypertension group without treatment | – | –Until 11,March, 2015, 60 cases are collected. |
| hypertension group with antihypertensive treatment | – | –(ACEI, beta-blocker, Ca blocker, Diuretics) prior to the surgery. Until 11,March, 2015, 59 cases are collected. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients enrolled will be divided into three groups as follows As the treatment and choice of drugs for hypertension is complex but internation guideline-oriented. We would like to enroll enough sample size in the hypertensive groups and subgroups. 1. Normaltension group (control group) 2. Hypertension without treatment 3. Hypertension with treatment as follows (according to subject's daily routine Tx, the PI not involved into the choice and further manitence of drugs) I. Hypertension with treatment with ACEI II. Hypertension with treatment with β blocker III. Hypertension with treatment with Ca channel blocker IV. Hypertension with treatment with diuretics
Key inclusion criteria (7 listed)
- 300 eligible subjects
- No contraindication for inhalation anesthesia
- Elective surgery
- Age between 20-75 y/o
- No contraindication for postoperative morphine pain control
Key exclusion criteria (7 listed)
- Liver disease
- Renal disease
- Those who is presumed to go to ICU after surgery
- The patients with dementia or conscious disturbance
- Pregnancy or breast feeding
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
Pain
Time frame: Post-operation Day1 to Day4
1 secondary outcome
Morphine consumption
Time frame: Post-operation Day1 to Day4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
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 Hypertension, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Apr 2015. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Yi Chia, Bachelor (88673468183, yychia@isca.vghks.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Post-operation Day1 to Day4). 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 1 Apr 2015; AzTrials last refreshed its copy on 8 Nov 2026.