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Completed

NCT Number: NCT02902380

The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexmedetomidine group

Drug

dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery

Control group

Drug

0.9% saline infusion

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2016
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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