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The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02902380
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Drug: dexmedetomidine group Drug: control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine Group
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
Drug: dexmedetomidine group
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery

Placebo Comparator: Control Group
0.9% saline infusion
Drug: control group
0.9% saline infusion




Primary Outcome Measures :
  1. Stress hormone level [ Time Frame: immediately after anesthetic induction ]
    The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.

  2. Stress hormone level [ Time Frame: 1 hour after start of surgery ]
    The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.

  3. Stress hormone level [ Time Frame: 2-hour after start of surgery ]
    The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.

  4. Stress hormone level [ Time Frame: 1 second after the end of surgery ]
    The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.

  5. Stress hormone level [ Time Frame: 1 hour after the end of surgery ]
    The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
  • patient scheduled for major spine surgery

Exclusion Criteria:

  • ASA physical status Ⅳ
  • congestive heart failure
  • severe hepatorenal disease
  • insulin dependent DM(diabetes mellitus)
  • cancer or metastasis
  • pregnancy
  • problem with communication

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): NCT02902380


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02902380    
Other Study ID Numbers: 4-2016-0644
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action