HypotensionNCT00207987
Changes in Cerebral Oxygenation During Deliberate Hypotensive Anesthesia
An observational study of Hypotension, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This is a study using cerebral oximetry to evaluate the safety of traditionally adopted hypotensive anesthesia. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Hypotension
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2003to Dec 2006
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 40 patients are going to receive complex spine surgery.
Who cannot join
- Neurologic diseases
- Hepatic or renal impairment
- Uncontrolled hypertension
- Cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Anesthetic Department, China Medical University Hospital
Taichung, 404
Yu C Liu, MD, 886-4-22052121 ext. 3562, liuyc@seed.net.tw
About this study
This is a study using cerebral oximetry to evaluate the safety of traditionally adopted hypotensive anesthesia.
Read the detailed description
The values of cerebral oximetry were analyzed between different stages of anesthetic management. The critical part of anesthetic management is to use the technique of controlled hypotension. The blood pressure was lowered to the level of MABP 50 or 60 mmHg depending on which group patients were assigned to.
The values of cerebral oximetry and side effects between 2 groups will be compared at the completion of data collection.
- Conditions
- Hypotension
- Keywords
- controlled hypotension
- Medical subject headings
- Hypotension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu C Liu, M.D., Principal investigator, Anesthetic Department, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207987
- Sponsor's protocol ID
- DMR-93-41
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation During Deliberate Hypotensive Anesthesia
- ClinicalTrials.gov ID
- NCT00207987
- Acronym / sponsor ID
- DMR-93-41
- Conditions
- Hypotension
- Keywords
- controlled hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Dec 2006
- First posted
- 21 Sep 2005 (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.
This is a study using cerebral oximetry to evaluate the safety of traditionally adopted hypotensive anesthesia.
Detailed description
The values of cerebral oximetry were analyzed between different stages of anesthetic management. The critical part of anesthetic management is to use the technique of controlled hypotension. The blood pressure was lowered to the level of MABP 50 or 60 mmHg depending on which group patients were assigned to.
The values of cerebral oximetry and side effects between 2 groups will be compared at the completion of data collection.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 40 patients are going to receive complex spine surgery.
Key exclusion criteria (4 listed)
- Neurologic diseases
- Hepatic or renal impairment
- Uncontrolled hypertension
- Cardiovascular diseases
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2007.
Related trials for Hypotension
Not yet recruiting
Applying HPI in Oral Cancer Surgery
the Severity and Duration of Intraoperative Hypotension
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
OB VEGA-Phenylephrine vs Norepinephrine Outcomes
Hypotension During Surgery, Cesarean Birth
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
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.
Yu C Liu, M.D. principal investigator
Anesthetic Department, China Medical University Hospital
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 Hypotension, run by China Medical University 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 1 inclusion and 4 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 21 Nov 2007. 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 Yu C Liu, M.D. (886-4-22052121 ext. 3562, liuyc@seed.net.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Nov 2007.