Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine

NCT04284150 | Unknown DMC

• 1 other identifier: 2019101201
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Supraventricular tachycardia (SVT) is a common arrhythmia in the perioperative period, which is associated with adverse stimulus such as cardiovascular risk factors, emotional tension, hypoxia, CO2 accumulation, hypokalemia, atropine and pain. To treat perioperative SVT, in addition to massage the vagus nerve, the use of antiarrhythmic drugs and other internal medicine classic methods, the cardiovascular protection of anesthetic drugs is also a common adjuvant treatment. Dexmedetomidine which is widely used as an adjuvant to general anesthesia, can excite α2 receptor to produce sedation, analgesia, inhibition of sympathetic activity, stabilization of hemodynamics and other effects. Dexmedetomidine is approved by FDA for use in operating room anesthesia and intensive care unit sedation in adults. Although dexmedetomidine is not approved for the treatment of arrhythmias, a growing number of evidences indicated dexmedetomidine can serve as a potential treatment for arrhythmias in perioperative patients. Liu et al. confirmed that dexmedetomidine can reduce ventricular rate and improve atrial fibrillation in cardiac surgery patient. Ji et al. showed that dexmedetomidine anesthesia can be effective in lowering cardiovascular and cerebrovascular complications and mortality in patients one year after coronary bypass surgery. A number of retrospective analyses of pediatric patients undergoing cardiac surgery have shown the incidence of perioperative SVT in patients treated with dexmedetomidine sedation is significantly decreased, which prompts that dexmedetomidine has the potential prevention and treatment for tachyarrhythmia. Therefore, the investigators selected dexmedetomidine for sedation in patients with perioperative SVT to explore the effect for treating SVT via its sedation and mechanism of anti-sympatheticon in this study.

Conditions

Perioperative Period

Keywords

Supraventricular tachycardia; Dexmedetomidine; Midazolam; Heart rate variability

Outcome Measures

Primary Outcomes (3)

• dexmedetomidine treat supraventricular tachycardia

  effective rate of dexmedetomidine on supraventricular tachycardia

  through study completion, up to 6 months

• midazolam treat supraventricular tachycardia

  effective rate of midazolam on supraventricular tachycardia

  through study completion, up to 6 months

• Comparison of efficacy of dexmedetomidine and midazolam in the treatment of SVT

  occurrence of SVT recorded before the infusion dexmedetomidine and midazolam (T0), 5 minutes after the infusion (T1), at the end of the infusion (T2), 5 minutes after the end of the infusion (T3) and 10 minutes after the end of the infusion (T4) in two groups

  through study completion, up to 6 months

Secondary Outcomes (7)

• alarm/sedation (OAA/S) score

  through study completion, up to 6 months

• heart rate (HR)

  through study completion, up to 6 months

• mean arterial pressure (MAP)

  through study completion, up to 6 months

• pulse oxygen saturation (SpO2)

  through study completion, up to 6 months

• normalized low frequency power

  through study completion, up to 6 months

Study Arms (1)

dexmedetomidine or Midazola treat supraventricular tachycardia

EXPERIMENTAL

Comparison of efficacy of dexmedetomidine and Midazolam in the treatment of SVT

Drug: Dexmedetomidine; Midazolam;

Interventions

Dexmedetomidine; Midazolam; DRUG

Treatment of supraventricular tachycardia in patients with non-cardiac surgery by dexmedetomidine during the perioperative period

Also known as: supraventricular tachycardia

dexmedetomidine or Midazola treat supraventricular tachycardia

Eligibility Criteria

• Age: 35 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with supraventricular tachycardia

You may not qualify if:

• Patients who suffered from significant hemodynamic instability, and can not receive dexmedetomidine and midazolam, were thus excluded from the study.
• Patients with other types of arrhythmia, not SVT, abnormal liver and kidney function and anaesthesia-related drug allergy, were excluded from the study.

Sponsors & Collaborators

• Lianyungang Hospital Affiliated Bengbu Medical College: lead

Related Publications (6)

• Alabed S, Sabouni A, Providencia R, Atallah E, Qintar M, Chico TJ. Adenosine versus intravenous calcium channel antagonists for supraventricular tachycardia. Cochrane Database Syst Rev. 2017 Oct 12;10(10):CD005154. doi: 10.1002/14651858.CD005154.pub4.

  PMID: 29025197 RESULT

• Zhu SJ, Wang KR, Zhang XX, Zhu SM. Relationship between genetic variation in the alpha2A-adrenergic receptor and the cardiovascular effects of dexmedetomidine in the Chinese Han population. J Zhejiang Univ Sci B. 2019 Jul;20(7):598-604. doi: 10.1631/jzus.B1800647.

  PMID: 31168973 RESULT

• Black N, D'Souza A, Wang Y, Piggins H, Dobrzynski H, Morris G, Boyett MR. Circadian rhythm of cardiac electrophysiology, arrhythmogenesis, and the underlying mechanisms. Heart Rhythm. 2019 Feb;16(2):298-307. doi: 10.1016/j.hrthm.2018.08.026. Epub 2018 Aug 29.

  PMID: 30170229 RESULT

• Jung W, Jang KI, Lee SH. Heart and Brain Interaction of Psychiatric Illness: A Review Focused on Heart Rate Variability, Cognitive Function, and Quantitative Electroencephalography. Clin Psychopharmacol Neurosci. 2019 Nov 20;17(4):459-474. doi: 10.9758/cpn.2019.17.4.459.

  PMID: 31671483 RESULT

• Chrysostomou C, Morell VO, Wearden P, Sanchez-de-Toledo J, Jooste EH, Beerman L. Dexmedetomidine: therapeutic use for the termination of reentrant supraventricular tachycardia. Congenit Heart Dis. 2013 Jan-Feb;8(1):48-56. doi: 10.1111/j.1747-0803.2012.00669.x. Epub 2012 May 22.

  PMID: 22613357 RESULT

• Liu X, Zhang K, Wang W, Xie G, Fang X. Dexmedetomidine sedation reduces atrial fibrillation after cardiac surgery compared to propofol: a randomized controlled trial. Crit Care. 2016 Sep 21;20(1):298. doi: 10.1186/s13054-016-1480-5.

  PMID: 27654700 RESULT

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Junlong Zhang, PhD

  the Affiliated Lianyungang No. 2 People's Hospital of Jiangsu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junlong Zhang, PhD

CONTACT

15715139688; zjlddqzyw@126.com

Yan Xu, PhD

CONTACT

18928380889; 18928380889@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients with supraventricular tachycardia

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 25, 2020
• Study Start: February 26, 2020
• Primary Completion: June 30, 2020
• Study Completion: August 30, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02