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Does Heart Rate Variablity (HRV) Predict Hypotension in Patients Undergoing Cervical Myelopathy Surgery ?

Does Heart Rate Variablity (HRV) Predict Hypotension on Induction in Patients Undergoing Surgery for Cervical Myelopathy ?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02360085
Enrollment
65
Registered
2015-02-10
Start date
2015-02-28
Completion date
2020-04-30
Last updated
2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate Variability

Keywords

Cervical Myelopathy, Hypotension

Brief 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.

Detailed description

Protocol 1. Standard perioperative management Routine standard preparation of the patients will be carried out as per the investigators institutional standard for all patients undergoing cervical spine surgery. All routine physiological monitoring (ECG, invasive arterial blood pressure, SPO2, end tidal CO2, temperature and depth of anaesthesia monitoring) will be performed. The induction of anesthesia will be performed with propofol (2-5 mg/kg), fentanyl (3mcg/Kg) and rocuronium (0.6 mg/kg) for intubation of the patient's trachea once peripheral nerve stimulation shows no muscle twitches. 2. Study protocol Before general anesthesia, following a 10 minute stabilization period with the patient lying supine and breathing at a rate of 12 - 15 breaths per minute, a 5 minute ECG recording will be obtained. ECG data will be downloaded onto a study laptop for later analysis using LabChart Software to determine HRV values. Hemodynamic data and depth of anaesthesia will be collected from the preinduction period until skin incision at 1 minute intervals. The study will be complete after skin incision. Data Collection and Management Data Collection The following data will be collected: patient demographics, surgical data including position technique, number of levels, duration, anaesthetic data including agents used, hemodynamic measurements from preinduction to surgical incision, Japanese Orthopaedic Association Score. The incidence of hypotension and the number of interventions required to keep mean arterial blood pressure above 70 mmHg will be recorded. Significance of the study Identifying patients at risk for hypotension can be useful to prevent hypotension and to prepare to treat hypotension sooner so that the risk of spinal cord ischemia can be minimized.

Interventions

None listed

Sponsors

Lashmi Venkatraghavan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

1. Patients with arrhythmias or absence of sinus rhythm 2. Diabetic patients 3. Degenerative neurological disease e.g. Parkinson's disease 4. Complete SCI 5. Inherited autonomic dysfunction

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability (HRV)1 dayDifference between total power (ms2) of patients in the hypotension group compared to stable group
HRV Indices1 dayDifferences in HRV indices between hypotension group and no hypotension group
Mean Arterial Pressureone dayPreoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group
HRV Indices AnalysisOne dayLow frequency (LF)/High frequency Ratio

Countries

Canada

Participant flow

Participants by arm

ArmCount
Cervical Myelopathy Undergoing Spine Surgery
This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018.
49
Total49

Baseline characteristics

CharacteristicCervical Myelopathy Undergoing Spine Surgery
Age, Customized
Female
55 years
STANDARD_DEVIATION 10.2
Cervical myelopathy
mild
37 Participants
Cervical myelopathy
moderate to severe
12 Participants
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Canada
49 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
35 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 49
other
Total, other adverse events
0 / 49
serious
Total, serious adverse events
0 / 49

Outcome results

Primary

Heart Rate Variability (HRV)

Difference between total power (ms2) of patients in the hypotension group compared to stable group

Time frame: 1 day

Population: All data are presented as Median \[Interquartile range\]

ArmMeasureValue (MEDIAN)
Hypotension GroupHeart Rate Variability (HRV)1439 ms2
No Hypotension GroupHeart Rate Variability (HRV)2191 ms2
Primary

HRV Indices

Differences in HRV indices between hypotension group and no hypotension group

Time frame: 1 day

Population: All data are presented as Median \[Interquartile range\]. VLF- very low frequency, LF-low frequency, HF- high frequency.

ArmMeasureGroupValue (MEDIAN)
Hypotension GroupHRV IndicesLF290.2 ms2
Hypotension GroupHRV IndicesHF109.7 ms2
Hypotension GroupHRV IndicesVLF684.8 ms2
No Hypotension GroupHRV IndicesLF406.5 ms2
No Hypotension GroupHRV IndicesHF350.4 ms2
No Hypotension GroupHRV IndicesVLF705.8 ms2
Primary

HRV Indices Analysis

Low frequency (LF)/High frequency Ratio

Time frame: One day

Population: Low Frequency to High Frequency ratio. All data are presented as Median \[Interquartile range\].

ArmMeasureValue (MEDIAN)
Hypotension GroupHRV Indices Analysis3.33 Ratio
No Hypotension GroupHRV Indices Analysis1.22 Ratio
Primary

Mean Arterial Pressure

Preoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group

Time frame: one day

Population: All data are presented as Median \[Interquartile range\]

ArmMeasureValue (MEDIAN)
Hypotension GroupMean Arterial Pressure96.0 mmHg
No Hypotension GroupMean Arterial Pressure104.3 mmHg

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026