Cervical Cord Compression and Hypertension

NCT ID: NCT04345822

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-08-31

Brief Summary

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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

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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

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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normotension

patients without diagnosis or treatment for hypertension

Decompression surgery

Intervention Type PROCEDURE

The surgeries aim to relieve the myelopathy from cord compression

hypertension

patients with diagnosis or treatment for hypertension

Decompression surgery

Intervention Type PROCEDURE

The surgeries aim to relieve the myelopathy from cord compression

Interventions

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Decompression surgery

The surgeries aim to relieve the myelopathy from cord compression

Intervention Type PROCEDURE

Other Intervention Names

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cervical spine decompression surgery

Eligibility Criteria

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Inclusion Criteria

* cervical spine surgery for cord compression

Exclusion Criteria

* spinal cord injury
* ASA class \>3
* chronic kidney disease
* congestive heart failure
* BMI\>30
* atrial fibrillation/ flutter
* obstructive sleep apnea
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MC HO, MD, PhD

Role: STUDY_CHAIR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei County, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ya-Chun Chu, MD, PhD

Role: CONTACT

+886-2-28757549

Wen-Cheng HUANG, MD, PhD

Role: CONTACT

+886-2-2875-7716

Facility Contacts

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MC Hou

Role: primary

+886-2-28757381

Other Identifiers

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2019_12_003CC

Identifier Type: -

Identifier Source: org_study_id

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