Does Heart Rate Variablity (HRV) Predict Hypotension in Patients Undergoing Cervical Myelopathy Surgery ?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02360085|
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : April 17, 2018
|Condition or disease|
|Heart Rate Variability|
- 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.
- 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|
|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 :||May 2018|
|Estimated Study Completion Date :||June 2018|
- Heart Rate Variability [ Time Frame: 1 day ]
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
|Contact: Lashmi Venkatraghavan, MDfirstname.lastname@example.org|
|Contact: Jigesh Mehta, MDemail@example.com|
|Toronto Western Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T2S8|
|Contact: Lashmi Venkatraghavan, MD 4166035118 firstname.lastname@example.org|
|Sub-Investigator: Alastair Moodley, MD|
|Sub-Investigator: Jigesh Mehta, MD|
|Sub-Investigator: Alison Tedder, MD|
|Sub-Investigator: Pirjo Manninen, MD|
|Principal Investigator:||Lashmi Venkatraghavan, MD||Department of Anesthesia, Toronto Western Hospital. University of Toronto|