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NCT Number: NCT01857141

Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy

The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients consented to spinal anesthesia were enrolled
  • Patients aged 40~70 years olds undergoing gastrectomy
  • No contraindication of epidural analgesia
  • ASA class I and II
  • Patients consented to epidural anesthesia were enrolled

Exclusion criteria

  • Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias
  • patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study

Treatment and study plan

preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)

Drug

Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of

normal saline

Drug

patients in the control groups received the equivalent volume of normal saline.

Primary outcomes

  1. Heart rate variability analysis

    Time frame: 5min perioids after fluid resuscitation.

    Heart rate variability analysis was performed according to the Task Force recommendations.

    Frequency domain analysis was based on fast Fourier transformation. Power spectrum densities were calculated for low frequencies (LF: 0.04-0.15 Hz) and high frequencies (HF: 0.15-0.4 Hz) informalized units, defined as the LF or HF proportional part of the total power.

    Baseline and 30min after the injection of the study drug.

Secondary outcomes

  1. Epidural injection

    Time frame: at 30 min after the epidural injection of the study drug

    And secondary data collection was done at 30 min after the epidural injection of the study drug.

    All of the HRV analysis was done before anaesthesia induction.

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Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 20, 2013
Registry last updated
Feb 5, 2014

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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