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

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: normal saline; Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)

• Registration Number: NCT01857141
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-05-12
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-04
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	-
dexmedetomidine	preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)	-

Primary Outcome Measures

Name	Time	Method
Heart rate variability analysis	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

Name	Time	Method
Epidural injection	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of