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

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ClinicalTrials.gov Identifier: NCT02360085
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Lashmi Venkatraghavan, University Health Network, Toronto

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.

Condition or disease
Heart Rate Variability

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Heart Rate Variablity (HRV) Predict Hypotension on Induction in Patients Undergoing Surgery for Cervical Myelopathy ?
Study Start Date : January 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cervical myelopathy presenting for cervical spine surgery at Toronto Western Hospital.
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360085


Contacts
Contact: Lashmi Venkatraghavan, MD 4166035118 lashmi.venkatraghavan@uhn.ca
Contact: Jigesh Mehta, MD 6476318264 jigesh.mehta@uhn.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Lashmi Venkatraghavan, MD    4166035118    lashmi.venkatraghavan@uhn.ca   
Sub-Investigator: Alastair Moodley, MD         
Sub-Investigator: Jigesh Mehta, MD         
Sub-Investigator: Alison Tedder, MD         
Sub-Investigator: Pirjo Manninen, MD         
Sponsors and Collaborators
Lashmi Venkatraghavan
Investigators
Principal Investigator: Lashmi Venkatraghavan, MD Department of Anesthesia, Toronto Western Hospital. University of Toronto

Responsible Party: Lashmi Venkatraghavan, Director, Neuroanesthesia, Toronto Western Hospital, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02360085     History of Changes
Other Study ID Numbers: UHN REB # 14-8164
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Keywords provided by Lashmi Venkatraghavan, University Health Network, Toronto:
Cervical Myelopathy
Hypotension

Additional relevant MeSH terms:
Hypotension
Spinal Cord Diseases
Bone Marrow Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases