Clinical trial · Interventional
Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy
NCT01857141CI-TRIAL-00013672completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| normal saline | Drug | — | UNRESOLVED |
| preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dexmedetomidine
- interventionNames
- Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)
- type
- PLACEBO_COMPARATOR
- label
- normal saline
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- Heart rate variability analysis
- timeFrame
- 5min perioids after fluid resuscitation.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBajwa 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
- BACKGROUNDChatzimichali 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
- BACKGROUNDHanss 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
- BACKGROUNDPenttila 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
- BACKGROUNDSchnaider 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