Surgical Complications From General AnesthesiaMHPCOSNCT02147275
Monitoring Hypertensive Patients's Cerebral Oxygen Saturation
An observational study of Surgical Complications From General Anesthesia and Hypertension, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Surgical Complications From General Anesthesia, Hypertension, Cerebral Ischemia
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Nov 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for major abdominal surgery such as gastrectomy, colon resection ,liver resection and duodenocephalo-pancreasectomy
Who may be able to join
- patients have hypertension more than 3 year,whether well-controlled or uncontrolled,
- scheduled for major abdominal surgery for at least 2 h
- under general anesthesia
- American Society of Anesthesiologists（ASA）physical status : II ~ III
- Age > 30
Who cannot join
- pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;
- ASA physical status >IV
- hepatic failure
- renal failure
- preoperative Mini-Mental State Examination (MMSE) score less than 24
- a history of cardiovascular surgery or craniotomy
- cardiac failure
- respiratory failure
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery
The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.
- Conditions
- Surgical Complications From General Anesthesia, Hypertension, Cerebral Ischemia, Cerebral Anoxia
- Keywords
- hypertension, cerebral oxygen saturation, near-infrared spectroscopy, cognitive function
- Medical subject headings
- Hypertension, Brain Ischemia, Hypoxia, Brain
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 |
|---|---|---|
| hypertension disease | patients have hypertension disease, whether well-controlled or uncontrolled, more than 3 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreases in cerebral oxygen saturation (rSO2) during the surgery
Measured: every 5 minutes throughout the surgery
Secondary outcomes (1)
Change from baseline in Mini-Mental State Exam (MMSE) perioperative period
Measured: Baseline, 4 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Complications From General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Hongyi, Huazhong University of Science and Technology
- Investigators
- Peng Wang, MD PHD, Study director, Vice Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147275
- Sponsor's protocol ID
- TJH-AD-12888
- Other IDs
- 75888
- Acronym
- MHPCOS
- Status last verified
- Nov 2014
- First submitted
- 22 May 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li H, Fu Q, Wu Z, Sun J, Manyande A, Yang H, Wang P. Cerebral oxygen desaturation occurs frequently in patients with hypertension undergoing major abdominal surgery. J Clin Monit Comput. 2018 Apr;32(2):285-293. doi: 10.1007/s10877-017-0024-0. Epub 2017 May 9.
PubMed 28488169
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02147275
- Acronym / sponsor ID
- MHPCOS / TJH-AD-12888
- Conditions
- Surgical Complications From General Anesthesia, Hypertension, Cerebral Ischemia, Cerebral Anoxia
- Keywords
- hypertension, cerebral oxygen saturation, near-infrared spectroscopy, cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 May 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.
The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertension disease | – | –patients have hypertension disease, whether well-controlled or uncontrolled, more than 3 year |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for major abdominal surgery such as gastrectomy, colon resection ,liver resection and duodenocephalo-pancreasectomy
Key inclusion criteria (5 listed)
- patients have hypertension more than 3 year,whether well-controlled or uncontrolled,
- scheduled for major abdominal surgery for at least 2 h
- under general anesthesia
- American Society of Anesthesiologists（ASA）physical status : II ~ III
- Age > 30
Key exclusion criteria (8 listed)
- pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;
- ASA physical status >IV
- hepatic failure
- renal failure
- preoperative Mini-Mental State Examination (MMSE) score less than 24
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
decreases in cerebral oxygen saturation (rSO2) during the surgery
Time frame: every 5 minutes throughout the surgery
1 secondary outcome
Change from baseline in Mini-Mental State Exam (MMSE) perioperative period
Time frame: Baseline, 4 day after surgery
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 11 Nov 2014.
- Derived from this study: PubMed 28488169Li H, Fu Q, Wu Z, Sun J, Manyande A, Yang H, Wang P. Cerebral oxygen desaturation occurs frequently in patients with hypertension undergoing major abdominal surgery. J Clin Monit Comput. 2018 Apr;32(2):285-293. doi: 10.1007/s10877-017-0024-0. Epub 2017 May 9.
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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.
Peng Wang, MD PHD study director
Vice Director
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 Surgical Complications From General Anesthesia and Hypertension, run by Huazhong University of Science and Technology 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 5 inclusion and 8 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 11 Nov 2014. 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?
decreases in cerebral oxygen saturation (rSO2) during the surgery (time frame: every 5 minutes throughout the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147275, which also lists 1 linked publication.
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 11 Nov 2014.