Cervical Cord Compression and Hypertension

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04345822
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Cervical Compressive Myelopathy on the Autonomic Nervous System and Clinical Implication
• Actual Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Mar 31, 2021
• Anticipated Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. change of blood pressure [one day before surgery, during surgery, 3 months after surgery, 6 months after surgery]

   noninvasive blood pressure

2. change of hear rate variability [one day before surgery, during surgery, 3 months after surgery, 6 months after surgery]

   from analysis of ECG

3. baroreflex activity [during surgery (anesthesia)]

   from analysis of arterial blood pressure waveform

Secondary Outcome Measures

1. change of Japanese Orthopaedic Association Scores [one day before surgery, 3 months after surgery, 6 months after surgery]

   17 points neurological assessment for cervical spine pathology (from 0~17; 0 denotes worst neurological condition, 17 denotes intact )

2. change of the Nurick scores [one day before surgery, 3 months after surgery, 6 months after surgery]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei county		Taiwan	11217

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT04345822
• Other Study ID Numbers: 2019_12_003CC
• First Posted: Apr 14, 2020
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taipei Veterans General Hospital, Taiwan: heart rate variability; cervical myelopathy; blood pressure; decompression
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Apr 14, 2020