An observational study in Hypertension, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Taipei Veterans General Hospital, Taiwan · Observational
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.
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.
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We exclude patients with other cormobidity that might lead to hypertension or hypetension. we perfrom age and gender matched pair.
Exclusion Criteria:
patients without diagnosis or treatment for hypertension
Procedure: Decompression surgery
patients with diagnosis or treatment for hypertension
Procedure: Decompression surgery
The surgeries aim to relieve the myelopathy from cord compression
Also known as: cervical spine decompression surgery
change of blood pressure
noninvasive blood pressure
Time frame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
change of hear rate variability
from analysis of ECG
Time frame: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
baroreflex activity
from analysis of arterial blood pressure waveform
Time frame: during surgery (anesthesia)
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 )
Time frame: 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)
Time frame: one day before surgery, 3 months after surgery, 6 months after surgery
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Taipei Veterans General Hospital, Taiwan