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

NCT01857141 | Completed

• 1 other identifier: 4-2011-0904
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

dexmedetomidine; heart rate variability; preemptive epidural; gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Epidural injection

  at 30 min after the epidural injection of the study drug

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

normal saline

PLACEBO COMPARATOR

Drug: normal saline

Interventions

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

dexmedetomidine

normal saline DRUG

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

normal saline

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

Related 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.

  PMID: 21712865 BACKGROUND

• 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.

  PMID: 21058941 BACKGROUND

• 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. doi: 10.1097/00000542-200603000-00022.

  PMID: 16508402 BACKGROUND

• Penttila 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. doi: 10.1139/y04-028.

  PMID: 15213737 BACKGROUND

• Schnaider TB, Vieira AM, Brandao 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. doi: 10.1590/s0034-70942005000500007. Portuguese.

  PMID: 19468643 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2013
• First Posted: May 20, 2013
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

KR (1)