Cognitive PerformanceNCT00827385
Intraoperative Blood Pressure and Cognitive Performance
An observational study of Cognitive Performance and Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively determine the association between incidence of neurological morbidity and minimum fractional blood pressure reached during laminectomy procedures under general anesthesia in hypertensive and normotensive subjects 40 years old and older. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cognitive Performance, Hypertension
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - individuals 40 years of age and older, undergoing laminectomy under general anesthesia.
Who may be able to join
- English as first language, or as a learned language as long as the patient is proficient
- No history of any neurological disease with the exception of patients without functional impairment who suffered a single episode of transient ischemic attack
- No history of axis I psychiatric diagnosis or drug abuse
- 40 years old or older
- Undergoing laminectomy under general anesthesia
- Must not take antihypertensive medication for purposes other than treatment of hypertension
Who cannot join
- Anyone who do not fit the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Hospital-Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Impact of Intraoperative Blood Pressure on Cognitive Performance in Patients With and Without Hypertension: a Prospective Observational Study
The purpose of this study is to prospectively determine the association between incidence of neurological morbidity and minimum fractional blood pressure reached during laminectomy procedures under general anesthesia in hypertensive and normotensive subjects 40 years old and older.
- Conditions
- Cognitive Performance, 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 |
|---|---|---|
| hypertensive | Not described | |
| normotensive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative cognitive performance
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827385
- Sponsor's protocol ID
- 0809009986
- Status last verified
- Feb 2015
- First submitted
- 21 Jan 2009
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Blood Pressure on Cognitive Performance in Patients With and Without Hypertension: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT00827385
- Acronym / sponsor ID
- 0809009986
- Conditions
- Cognitive Performance, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Jan 2009 (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 prospectively determine the association between incidence of neurological morbidity and minimum fractional blood pressure reached during laminectomy procedures under general anesthesia in hypertensive and normotensive subjects 40 years old and older.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive | – | – |
| normotensive | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - individuals 40 years of age and older, undergoing laminectomy under general anesthesia.
Key inclusion criteria (6 listed)
- English as first language, or as a learned language as long as the patient is proficient
- No history of any neurological disease with the exception of patients without functional impairment who suffered a single episode of transient ischemic attack
- No history of axis I psychiatric diagnosis or drug abuse
- 40 years old or older
- Undergoing laminectomy under general anesthesia
Key exclusion criteria (1 listed)
- Anyone who do not fit the inclusion criteria.
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
post-operative cognitive performance
Time frame: 1
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 4 Feb 2015.
Related trials for Cognitive Performance
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruiting
Effects of Cognitive Restructuring Intervention on Competitive State Anxiety and Volleyball Skill Performance Among Female Collegiate Volleyball Players in Guangzhou, China
Competitive State Anxiety, Volleyball Skill Performance
Not yet recruiting
Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Cognition, Dual-Task Performance, and Interoceptive Accuracy
Cognition, Healthy Volunteers
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Not yet recruiting
Back Massage Before a Cognitive Task in Healthy Young Adults
Cognitive Performance in Healthy Adults
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 Cognitive Performance and Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 4 Feb 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 United States. 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?
post-operative cognitive performance (time frame: 1). 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 4 Feb 2015.