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

Primary Purpose

Perioperative Period

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine; Midazolam;
Sponsored by
Lianyungang Hospital Affiliated Bengbu Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Period focused on measuring Supraventricular tachycardia, Dexmedetomidine, Midazolam, Heart rate variability

Eligibility Criteria

35 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with supraventricular tachycardia

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    dexmedetomidine or Midazola treat supraventricular tachycardia

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    dexmedetomidine treat supraventricular tachycardia
    effective rate of dexmedetomidine on supraventricular tachycardia
    midazolam treat supraventricular tachycardia
    effective rate of midazolam on supraventricular tachycardia
    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

    Secondary Outcome Measures

    alarm/sedation (OAA/S) score
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    heart rate (HR)
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    mean arterial pressure (MAP)
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    pulse oxygen saturation (SpO2)
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    normalized low frequency power
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    normalized high frequency power
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    the balance ratio of sympathetic to vagal tone
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT

    Full Information

    First Posted
    February 13, 2020
    Last Updated
    February 22, 2020
    Sponsor
    Lianyungang Hospital Affiliated Bengbu Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04284150
    Brief Title
    Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine
    Official Title
    Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine During the Perioperative Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 26, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    August 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lianyungang Hospital Affiliated Bengbu Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Forty patients with SVT of both sexes, aged 35-61 yr, of American Society of Anesthesiologists physical status Ⅰ-Ⅱ, who undergo elective surgery, were randomly divided into two groups (n=30) including dexmedetomidine group (group D) and midazolam group (group M). For comparison of the efficacy of dexmedetomidine and midazolam in the treatment of SVT, the following needs to be done. The patients calm down for 5-10 minutes after getting into the operating room, group D and group M started as a continuous infusion with dexmedetomidine 0.5µg/kg or midazolam 0.06mg/kg using a micro-pump for 10 minutes. The alarm/sedation (OAA/S) score, heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO2) and occurrence of SVT were recorded before the infusion (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, miniature electrocardiograph was used to monitor the frequency domain index of heart rate variability (HRV) in 5 minutes at each time point including normalized low frequency power (LFnorm), normalized high frequency power (HFnorm) and the balance ratio of sympathetic to vagal tone (LF/HF).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perioperative Period
    Keywords
    Supraventricular tachycardia, Dexmedetomidine, Midazolam, Heart rate variability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    patients with supraventricular tachycardia
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dexmedetomidine or Midazola treat supraventricular tachycardia
    Arm Type
    Experimental
    Arm Description
    Comparison of efficacy of dexmedetomidine and Midazolam in the treatment of SVT
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine; Midazolam;
    Other Intervention Name(s)
    supraventricular tachycardia
    Intervention Description
    Treatment of supraventricular tachycardia in patients with non-cardiac surgery by dexmedetomidine during the perioperative period
    Primary Outcome Measure Information:
    Title
    dexmedetomidine treat supraventricular tachycardia
    Description
    effective rate of dexmedetomidine on supraventricular tachycardia
    Time Frame
    through study completion, up to 6 months
    Title
    midazolam treat supraventricular tachycardia
    Description
    effective rate of midazolam on supraventricular tachycardia
    Time Frame
    through study completion, up to 6 months
    Title
    Comparison of efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Description
    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
    Time Frame
    through study completion, up to 6 months
    Secondary Outcome Measure Information:
    Title
    alarm/sedation (OAA/S) score
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months
    Title
    heart rate (HR)
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months
    Title
    mean arterial pressure (MAP)
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months
    Title
    pulse oxygen saturation (SpO2)
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months
    Title
    normalized low frequency power
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months
    Title
    normalized high frequency power
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months
    Title
    the balance ratio of sympathetic to vagal tone
    Description
    This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT This indicator was 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 for evaluating the efficacy of dexmedetomidine and midazolam in the treatment of SVT
    Time Frame
    through study completion, up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    61 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with supraventricular tachycardia Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junlong Zhang, PhD
    Phone
    15715139688
    Email
    zjlddqzyw@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Xu, PhD
    Phone
    18928380889
    Email
    18928380889@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Junlong Zhang, PhD
    Organizational Affiliation
    the Affiliated Lianyungang No. 2 People's Hospital of Jiangsu University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29025197
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31168973
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30170229
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31671483
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22613357
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27654700
    Citation
    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.
    Results Reference
    result

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

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