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Clinical Trials/NCT01857141
NCT01857141
Completed
Not Applicable

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

Yonsei University1 site in 1 country38 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)
Conditions
Gastric Cancer
Sponsor
Yonsei University
Enrollment
38
Locations
1
Primary Endpoint
Heart rate variability analysis
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

dexmedetomidine

Intervention: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)

normal saline

Intervention: normal saline

Outcomes

Primary Outcomes

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

  • Epidural injection(at 30 min after the epidural injection of the study drug)

Study Sites (1)

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