Skip to content

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

Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine During the Perioperative Period

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04284150
Enrollment
60
Registered
2020-02-25
Start date
2020-02-26
Completion date
2020-08-30
Last updated
2020-02-25

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

Conditions

Perioperative Period

Keywords

Supraventricular tachycardia, Dexmedetomidine, Midazolam, Heart rate variability

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).

Interventions

DRUGDexmedetomidine; Midazolam;

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

Sponsors

Lianyungang Hospital Affiliated Bengbu Medical College
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

patients with supraventricular tachycardia

Eligibility

Sex/Gender
ALL
Age
35 Years to 61 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
dexmedetomidine treat supraventricular tachycardiathrough study completion, up to 6 monthseffective rate of dexmedetomidine on supraventricular tachycardia
midazolam treat supraventricular tachycardiathrough study completion, up to 6 monthseffective rate of midazolam on supraventricular tachycardia
Comparison of efficacy of dexmedetomidine and midazolam in the treatment of SVTthrough study completion, up to 6 monthsoccurrence 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

MeasureTime frameDescription
pulse oxygen saturation (SpO2)through study completion, up to 6 monthsThis 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 powerthrough study completion, up to 6 monthsThis 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
alarm/sedation (OAA/S) scorethrough study completion, up to 6 monthsThis 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 tonethrough study completion, up to 6 monthsThis 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
normalized high frequency powerthrough study completion, up to 6 monthsThis 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)through study completion, up to 6 monthsThis 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)through study completion, up to 6 monthsThis 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

Contacts

Primary ContactJunlong Zhang, PhD
zjlddqzyw@126.com15715139688
Backup ContactYan Xu, PhD
18928380889@126.com18928380889

Outcome results

None listed

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