Clinical trial NCT04345822: Cervical Cord Compression and Hypertension
Official title: Effect of Cervical Compressive Myelopathy on the Autonomic Nervous System and Clinical Implication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: heart rate variability
cervical myelopathy
blood pressure
decompression
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We exclude patients with other cormobidity that might lead to hypertension or hypetension. we perfrom age and gender matched pair.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change of blood pressure
timeFrame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
measure: change of hear rate variability
timeFrame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
measure: baroreflex activity
timeFrame: during surgery (anesthesia)
Secondary outcomes:
measure: change of Japanese Orthopaedic Association Scores
timeFrame: one day before surgery, 3 months after surgery, 6 months after surgery
measure: change of the Nurick scores
timeFrame: one day before surgery, 3 months after surgery, 6 months after surgery
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: MC HO, MD, PhD
role: STUDY_CHAIR
References: