Cervical Cord Compression and Hypertension

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Procedure: Decompression surgery

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: MC Hou; Phone Number: +886-2-28757381

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normotension; patients without diagnosis or treatment for hypertension	Procedure: Decompression surgery; The surgeries aim to relieve the myelopathy from cord compression; Other Names: cervical spine decompression surgery
hypertension; patients with diagnosis or treatment for hypertension	Procedure: Decompression surgery; The surgeries aim to relieve the myelopathy from cord compression; Other Names: cervical spine decompression surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of blood pressure	noninvasive blood pressure	one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
change of hear rate variability	from analysis of ECG	one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
baroreflex activity	from analysis of arterial blood pressure waveform	during surgery (anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 )	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)	one day before surgery, 3 months after surgery, 6 months after surgery

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: MC HO, MD, PhD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ANTICIPATED): March 31, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 12, 2020
• First Posted (ACTUAL): April 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: blood pressure; heart rate variability; decompression; cervical myelopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2019_12_003CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No