Postoperative ComplicationsNCT01884298
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity
An observational study of Postoperative Complications, run by Peking University First Hospital at 1 site in China.
Trial summary
In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Postoperative Complications
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2013to 2 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults aged 50-70 with isolated systolic hypertension .
Who may be able to join
- adults aged 50-70 with isolated systolic hypertension .
Who cannot join
- age < 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 < 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine > 50% or liver enzymes > 50% upper limit of normal values)
Trial locations and contacts
1 site in 1 country.
About this study
In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. however, the epidural technique often causes more drop of blood pressure, especially in dehydrated patients. The investigators designed the trial to see if the benefit weigh out the potential risk of epidural in isolated hypertensive patients.
- Conditions
- Postoperative Complications
- Keywords
- remifentanil, isolated systolic hypertension, morbidity, epidural combined general anesthesia
- Medical subject headings
- Postoperative Complications, Isolated Systolic 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 |
|---|---|---|
| patients receive either epidural or non epidural depends on doctor responsible | epidural or non epidural | |
| patients receive epidural depends on doctor responsible | patients receive non epidural depends on doctor responsible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
days
Measured: 5 weeks
cardiovascular morbidity
case
Measured: 2 weeks
respiratory morbidity
case
Measured: 2 weeks
postoperative renal failure
case
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start2 Jul 2013 (estimated)
- Primary completion2 Dec 2015 (estimated)
- Study completion2 Dec 2015 (estimated)
Why it stopped: change of plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhou, MD, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884298
- Sponsor's protocol ID
- EPIISO-021
- Status last verified
- May 2026
- First submitted
- 19 Jun 2013
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity
- ClinicalTrials.gov ID
- NCT01884298
- Acronym / sponsor ID
- EPIISO-021
- Conditions
- Postoperative Complications
- Keywords
- remifentanil, isolated systolic hypertension, morbidity, epidural combined general anesthesia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: change of plan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 2 Jul 2013 (estimated)
- Primary completion
- 2 Dec 2015 (estimated)
- Study completion
- 2 Dec 2015 (estimated)
- First posted
- 24 Jun 2013 (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.
In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. however, the epidural technique often causes more drop of blood pressure, especially in dehydrated patients. The investigators designed the trial to see if the benefit weigh out the potential risk of epidural in isolated hypertensive patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receive either epidural or non epidural depends on doctor responsible | – | –epidural or non epidural |
| patients receive epidural depends on doctor responsible | – | –patients receive non epidural depends on doctor responsible |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults aged 50-70 with isolated systolic hypertension .
Key inclusion criteria (1 listed)
- adults aged 50-70 with isolated systolic hypertension .
Key exclusion criteria (1 listed)
- age < 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 < 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine > 50% or liver enzymes > 50% upper limit of normal values)
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
Length of postoperative hospital stay
Time frame: 5 weeks
days
cardiovascular morbidity
Time frame: 2 weeks
case
respiratory morbidity
Time frame: 2 weeks
case
postoperative renal failure
Time frame: 2 weeks
case
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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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.
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 Postoperative Complications, run by Peking University First Hospital 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 May 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Length of postoperative hospital stay (time frame: 5 weeks). The study lists 4 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 20 May 2026.