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

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857141
• Other study ID #: 4-2011-0904
• Status: Completed
• Phase: N/A
• First received: May 12, 2013
• Last updated: February 4, 2014
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Bajwa SJ, Bajwa SK, Kaur J, Singh G, Arora V, Gupta S, Kulshrestha A, Singh A, Parmar S, Singh A, Goraya S. Dexmedetomidine and clonidine in epidural anaesthesia: A comparative evaluation. Indian J Anaesth. 2011 Mar;55(2):116-21. doi: 10.4103/0019-5049.79883. — View Citation

Chatzimichali A, Zoumprouli A, Metaxari M, Apostolakis I, Daras T, Tzanakis N, Askitopoulou H. Heart rate variability may identify patients who will develop severe bradycardia during spinal anaesthesia. Acta Anaesthesiol Scand. 2011 Feb;55(2):234-41. doi: 10.1111/j.1399-6576.2010.02339.x. Epub 2010 Nov 8. — View Citation

Hanss R, Bein B, Weseloh H, Bauer M, Cavus E, Steinfath M, Scholz J, Tonner PH. Heart rate variability predicts severe hypotension after spinal anesthesia. Anesthesiology. 2006 Mar;104(3):537-45. — View Citation

Penttilä J, Helminen A, Anttila M, Hinkka S, Scheinin H. Cardiovascular and parasympathetic effects of dexmedetomidine in healthy subjects. Can J Physiol Pharmacol. 2004 May;82(5):359-62. — View Citation

Schnaider TB, Vieira AM, Brandão AC, Lobo MV. [Intraoperative analgesic effect of epidural ketamine, clonidine or dexmedetomidine for upper abdominal surgery.]. Rev Bras Anestesiol. 2005 Oct;55(5):525-31. Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability analysis	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.	5min perioids after fluid resuscitation.	No
Secondary	Epidural injection	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.	at 30 min after the epidural injection of the study drug	No