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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01857141
Enrollment
38
Registered
2013-05-20
Start date
2012-02-29
Completion date
2013-08-31
Last updated
2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

dexmedetomidine, heart rate variability, preemptive epidural, gastrectomy

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.

Interventions

DRUGpreemptive 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

DRUGnormal saline

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability analysis5min 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

MeasureTime frameDescription
Epidural injectionat 30 min after the epidural injection of the study drugAnd 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026