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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284150
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Lianyungang Hospital Affiliated Bengbu Medical College

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.


Condition or disease Intervention/treatment Phase
Perioperative Period Drug: Dexmedetomidine; Midazolam; Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: patients with supraventricular tachycardia
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine During the Perioperative Period
Estimated Study Start Date : February 26, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine or Midazola treat supraventricular tachycardia
Comparison of efficacy of dexmedetomidine and Midazolam in the treatment of SVT
Drug: Dexmedetomidine; Midazolam;
Treatment of supraventricular tachycardia in patients with non-cardiac surgery by dexmedetomidine during the perioperative period
Other Name: supraventricular tachycardia




Primary Outcome Measures :
  1. dexmedetomidine treat supraventricular tachycardia [ Time Frame: through study completion, up to 6 months ]
    effective rate of dexmedetomidine on supraventricular tachycardia

  2. midazolam treat supraventricular tachycardia [ Time Frame: through study completion, up to 6 months ]
    effective rate of midazolam on supraventricular tachycardia

  3. Comparison of efficacy of dexmedetomidine and midazolam in the treatment of SVT [ Time Frame: through study completion, up to 6 months ]
    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 :
  1. alarm/sedation (OAA/S) score [ Time Frame: through study completion, up to 6 months ]
    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

  2. heart rate (HR) [ Time Frame: through study completion, up to 6 months ]
    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

  3. mean arterial pressure (MAP) [ Time Frame: through study completion, up to 6 months ]
    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

  4. pulse oxygen saturation (SpO2) [ Time Frame: through study completion, up to 6 months ]
    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

  5. normalized low frequency power [ Time Frame: through study completion, up to 6 months ]
    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

  6. normalized high frequency power [ Time Frame: through study completion, up to 6 months ]
    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

  7. the balance ratio of sympathetic to vagal tone [ Time Frame: through study completion, up to 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284150


Contacts
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Contact: Junlong Zhang, PhD 15715139688 zjlddqzyw@126.com
Contact: Yan Xu, PhD 18928380889 18928380889@126.com

Sponsors and Collaborators
Lianyungang Hospital Affiliated Bengbu Medical College
Investigators
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Principal Investigator: Junlong Zhang, PhD the Affiliated Lianyungang No. 2 People's Hospital of Jiangsu University

Publications of Results:

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Responsible Party: Lianyungang Hospital Affiliated Bengbu Medical College
ClinicalTrials.gov Identifier: NCT04284150    
Other Study ID Numbers: 2019101201
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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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
Keywords provided by Lianyungang Hospital Affiliated Bengbu Medical College:
Supraventricular tachycardia
Dexmedetomidine
Midazolam
Heart rate variability
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators