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Cervical Cord Compression and Hypertension

Effect of Cervical Compressive Myelopathy on the Autonomic Nervous System and Clinical Implication

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04345822
Enrollment
100
Registered
2020-04-14
Start date
2020-02-01
Completion date
2021-08-31
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

heart rate variability, cervical myelopathy, blood pressure, decompression

Brief 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.

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.

Interventions

The surgeries aim to relieve the myelopathy from cord compression

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of blood pressureone day before surgery, during surgery, 3 months after surgery, 6 months after surgerynoninvasive blood pressure
change of hear rate variabilityone day before surgery, during surgery, 3 months after surgery, 6 months after surgeryfrom analysis of ECG
baroreflex activityduring surgery (anesthesia)from analysis of arterial blood pressure waveform

Secondary

MeasureTime frameDescription
change of Japanese Orthopaedic Association Scoresone day before surgery, 3 months after surgery, 6 months after surgery17 points neurological assessment for cervical spine pathology (from 0\ 17; 0 denotes worst neurological condition, 17 denotes intact )
change of the Nurick scoresone day before surgery, 3 months after surgery, 6 months after surgery6 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)

Countries

Taiwan

Contacts

Primary ContactYa-Chun Chu, MD, PhD
yachunchu@gmail.com+886-2-28757549
Backup ContactWen-Cheng HUANG, MD, PhD
wchuang518@gmail.com+886-2-2875-7716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026