Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02360085
Other study ID # 14-8164
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date April 2020

Study information

Verified date December 2022
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date April 2020
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lashmi Venkatraghavan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart Rate Variability (HRV) Difference between total power (ms2) of patients in the hypotension group compared to stable group 1 day
Primary HRV Indices Differences in HRV indices between hypotension group and no hypotension group 1 day
Primary Mean Arterial Pressure Preoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group one day
Primary HRV Indices Analysis Low frequency (LF)/High frequency Ratio One day
See also
  Status Clinical Trial Phase
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Completed NCT02153385 - Effects of Yoga on Heart Rate Variability and Mood in Women N/A
Terminated NCT04381182 - Heart Rate Variability and Stress Management Enhancement N/A
Active, not recruiting NCT04342078 - Vitamin D and Health Outcomes in Preterm Born Population
Completed NCT03068182 - Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects. N/A
Recruiting NCT06101225 - Effects of a Relaxation and Guided Imagery Intervention in School Context N/A
Recruiting NCT05679882 - Effects of Natural Sounds on Attention Restoration Outdoors N/A
Recruiting NCT05950698 - Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
Completed NCT05093439 - Heart Rate Variability at the Emergency Department
Completed NCT04487899 - Analysis of Heart Rate Variability During Emergency Flight Simulator Missions in Fighter Pilots
Recruiting NCT05560893 - The Heart of the Community Study N/A
Completed NCT04869176 - Effect of Caffeine on Heart Rate Variability in Newborns N/A
Recruiting NCT06425939 - Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance N/A
Recruiting NCT05869721 - Effects of Yoga on Women With Breast Cancer N/A
Recruiting NCT06450483 - Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes N/A
Completed NCT02137057 - The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients N/A
Completed NCT01908920 - Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects N/A
Not yet recruiting NCT05296616 - Sleep Quality, Stress Level and Heart Rate Variability of University Students N/A
Recruiting NCT04826601 - The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy N/A