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

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: NCT01857141
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) Drug: normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)
Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of

Placebo Comparator: normal saline Drug: normal saline
patients in the control groups received the equivalent volume of normal saline.




Primary Outcome Measures :
  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 Outcome Measures :
  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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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01857141


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01857141    
Other Study ID Numbers: 4-2011-0904
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Keywords provided by Yonsei University:
dexmedetomidine
heart rate variability
preemptive epidural
gastrectomy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach 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