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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)

normal saline

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring dexmedetomidine, heart rate variability, preemptive epidural, gastrectomy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dexmedetomidine

normal saline

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01857141

First Posted

May 12, 2013

Last Updated

February 4, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01857141

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

dexmedetomidine, heart rate variability, preemptive epidural, gastrectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine

Arm Type

Experimental

Arm Title

normal saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)

Intervention Description

Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Heart rate variability analysis

Description

Time Frame

5min perioids after fluid resuscitation.

Secondary Outcome Measure Information:

Title

Epidural injection

Description

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.

Time Frame

at 30 min after the epidural injection of the study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

21712865

Citation

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.

Results Reference

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PubMed Identifier

21058941

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.

Results Reference

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PubMed Identifier

16508402

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. doi: 10.1097/00000542-200603000-00022.

Results Reference

background

PubMed Identifier

15213737

Citation

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.

Results Reference

background

PubMed Identifier

19468643

Citation

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.

Results Reference

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

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