HypertensionNCT04345822
Cervical Cord Compression and Hypertension
An observational study of Hypertension, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. Anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. We aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Decompression surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 31 Aug 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We exclude patients with other cormobidity that might lead to hypertension or hypetension. we perfrom age and gender matched pair.
Who may be able to join
- cervical spine surgery for cord compression
Who cannot join
- spinal cord injury
- ASA class >3
- chronic kidney disease
- congestive heart failure
- BMI>30
- atrial fibrillation/ flutter
- obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei County, 11217
MC Hou, +886-2-28757381
About this study
Official title: Effect of Cervical Compressive Myelopathy on the Autonomic Nervous System and Clinical Implication
Myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. Anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. We aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study.
Read the detailed description
It had been reported the cervical spondylotic myelopathy may lead to the development of hypertension. Decompression surgeries ameliorated neurological symptoms as well as the blood pressure. The cause may be the abnormality of autonomic dysfunction developed after myelopathy. However, the evidence was weak. We have noticed a tendency of hypotension during anesthesia in patients undergroing cervical spine surgeries, especially in surgeries of long levels and hypertensive patients. Thus we postulate the autonomic activity is abnormal in patients with cervical myelopathy. Sympathetic hyperactivity developed in order to maintain adequate perfusion to the cervical cord. When patients are under anesthesia, the sympathetic tone is suppressed, thus leading to severe hypotension that require the treatment of inotropic treatment. Heart rate variability (HRV) is a good index of autonomic activity. Thus we plan to Therefore we will measure the HRV (analysis of ECG) and baroreflex activity (analysis of arterial line during the anesthesia) in patients undergoing cervical spine surgeries for decompression of cord compression perioperatively. The primary end-point is the comparison of severity of cord compression between normotensive and hypertensive patients with cervical myelopathy. The secondary end-point is to compare blood pressure and HRV pre- and postoperatively. The third end-point is to elucidate the causative factors for severe hypotension during anesthesia.
- Conditions
- Hypertension
- Being tested
- Decompression surgery
- Keywords
- heart rate variability, cervical myelopathy, blood pressure, decompression
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression surgeryProcedure or surgery
Also called cervical spine decompression surgery
The surgeries aim to relieve the myelopathy from cord compression
| Study group | Role | What they receive |
|---|---|---|
| normotension | patients without diagnosis or treatment for hypertension Receives: Procedure: Decompression surgery | |
| hypertension | patients with diagnosis or treatment for hypertension Receives: Procedure: Decompression surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of blood pressure
noninvasive blood pressure
Measured: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
change of hear rate variability
from analysis of ECG
Measured: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
baroreflex activity
from analysis of arterial blood pressure waveform
Measured: during surgery (anesthesia)
Secondary outcomes (2)
change of Japanese Orthopaedic Association Scores
17 points neurological assessment for cervical spine pathology (from 0~17; 0 denotes worst neurological condition, 17 denotes intact )
Measured: one day before surgery, 3 months after surgery, 6 months after surgery
change of the Nurick scores
6 grades neurological assessment for cervical spine pathology (Grade 0: no root or cord symptoms; 1, signs or symptoms of root involvement only; 2, signs of spinal cord involvement (normal gait); 3, mild gait abnormality (does not prevent employment); 4, gait abnormality prevents employment; 5, only able to walk with assistance; 6, chair bound or bedridden)
Measured: one day before surgery, 3 months after surgery, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Feb 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Aug 2021 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- MC HO, MD, PhD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345822
- Sponsor's protocol ID
- 2019_12_003CC
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Compressive Myelopathy on the Autonomic Nervous System and Clinical Implication
- ClinicalTrials.gov ID
- NCT04345822
- Acronym / sponsor ID
- 2019_12_003CC
- Conditions
- Hypertension
- Keywords
- heart rate variability, cervical myelopathy, blood pressure, decompression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 14 Apr 2020 (actual)
- 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.
Myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. Anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. We aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study.
Detailed description
It had been reported the cervical spondylotic myelopathy may lead to the development of hypertension. Decompression surgeries ameliorated neurological symptoms as well as the blood pressure. The cause may be the abnormality of autonomic dysfunction developed after myelopathy. However, the evidence was weak. We have noticed a tendency of hypotension during anesthesia in patients undergroing cervical spine surgeries, especially in surgeries of long levels and hypertensive patients. Thus we postulate the autonomic activity is abnormal in patients with cervical myelopathy. Sympathetic hyperactivity developed in order to maintain adequate perfusion to the cervical cord. When patients are under anesthesia, the sympathetic tone is suppressed, thus leading to severe hypotension that require the treatment of inotropic treatment. Heart rate variability (HRV) is a good index of autonomic activity. Thus we plan to Therefore we will measure the HRV (analysis of ECG) and baroreflex activity (analysis of arterial line during the anesthesia) in patients undergoing cervical spine surgeries for decompression of cord compression perioperatively. The primary end-point is the comparison of severity of cord compression between normotensive and hypertensive patients with cervical myelopathy. The secondary end-point is to compare blood pressure and HRV pre- and postoperatively. The third end-point is to elucidate the causative factors for severe hypotension during anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normotension | – | Procedure: Decompression surgerypatients without diagnosis or treatment for hypertension |
| hypertension | – | Procedure: Decompression surgerypatients with diagnosis or treatment for hypertension |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We exclude patients with other cormobidity that might lead to hypertension or hypetension. we perfrom age and gender matched pair.
Key inclusion criteria (1 listed)
- cervical spine surgery for cord compression
Key exclusion criteria (7 listed)
- spinal cord injury
- ASA class >3
- chronic kidney disease
- congestive heart failure
- BMI>30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompression surgeryAlso: cervical spine decompression surgeryThe surgeries aim to relieve the myelopathy from cord compression | Procedure or surgery | hypertension, normotension |
Primary outcome
change of blood pressure
Time frame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
noninvasive blood pressure
change of hear rate variability
Time frame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
from analysis of ECG
baroreflex activity
Time frame: during surgery (anesthesia)
from analysis of arterial blood pressure waveform
2 secondary outcomes
change of Japanese Orthopaedic Association Scores
Time frame: one day before surgery, 3 months after surgery, 6 months after surgery
change of the Nurick scores
Time frame: one day before surgery, 3 months after surgery, 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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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.
MC HO, MD, PhD study chair
Taipei Veterans General Hospital, Taiwan
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 Taipei Veterans General Hospital, Taiwan 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 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 14 Apr 2020. 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 Ya-Chun Chu, MD, PhD (+886-2-28757549, yachunchu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of blood pressure (time frame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery). The study lists 3 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 14 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.