Cervical Cord Compression and Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345822
• Other study ID #: 2019_12_003CC
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ya-Chun Chu, MD, PhD
• Phone: +886-2-28757549
• Email: yachunchu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Procedure:
• Decompression surgery
The surgeries aim to relieve the myelopathy from cord compression

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of blood pressure	noninvasive blood pressure	one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
Primary	change of hear rate variability	from analysis of ECG	one day before surgery, during surgery, 3 months after surgery, 6 months after surgery
Primary	baroreflex activity	from analysis of arterial blood pressure waveform	during surgery (anesthesia)
Secondary	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
Secondary	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