N/A
Completed N=65
Does Heart Rate Variablity (HRV) Predict Hypotension in Patients Undergoing Cervical Myelopathy Surgery ?
Source: ClinicalTrials.gov NCT02360085 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Heart Rate Variability (HRV) — 1439; 2191 ms2
Summary
Cervical myelopathy is commonly associated with degenerative spinal disease. Dysfunction of the autonomic nervous system is also evident in many cases of cervical myelopathy. Autonomic dysfunction may result in haemodynamic instability and hypotension under anaesthesia. It is important to maintain adequate mean arterial pressure in order to perfuse the spinal cord and prevent cord ischemia. Heart rate variability, the physiological variations of the differences between heart beats, has been used to diagnose autonomic dysfunction. In patients with cervical myelopathy it may enable the anaesthetist to predict hypotension thereby allowing for early treatment and prevention of spinal cord ischemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Variability (HRV) |
1439; 2191 | — |
| PRIMARY HRV Indices |
684.8; 705.8; 290.2; 406.5; 109.7; 350.4 | — |
| PRIMARY Mean Arterial Pressure |
96.0; 104.3 | — |
| PRIMARY HRV Indices Analysis |
3.33; 1.22 | — |
Eligibility Criteria
Inclusion Criteria
- Adults patients, aged 18 - 70 years with the history of cervical myelopathy, presenting for anterior or posterior cervical decompression and fusion.
Exclusion Criteria
- Patients with arrhythmias or absence of sinus rhythm
- Diabetic patients
- Degenerative neurological disease e.g. Parkinson's disease
- Complete SCI
- Inherited autonomic dysfunction
Data sourced from ClinicalTrials.gov (NCT02360085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.