Perioperative PeriodNCT04284150
Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine
A study testing Dexmedetomidine; Midazolam; in people with Perioperative Period, run by Lianyungang Hospital Affiliated Bengbu Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 61 years
- Conditions the study is for
- Perioperative Period
- What is being tested?
- Dexmedetomidine; Midazolam;
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2020to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with supraventricular tachycardia
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine During the Perioperative Period
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.
Read the 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).
- Conditions
- Perioperative Period
- Being tested
- Dexmedetomidine; Midazolam;
- Keywords
- Supraventricular tachycardia, Dexmedetomidine, Midazolam, Heart rate variability
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine; Midazolam;Drug
Also called supraventricular tachycardia
Treatment of supraventricular tachycardia in patients with non-cardiac surgery by dexmedetomidine during the perioperative period
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine or Midazola treat supraventricular tachycardia | Experimental | Comparison of efficacy of dexmedetomidine and Midazolam in the treatment of SVT Receives: Drug: Dexmedetomidine; Midazolam; |
What is being measured
The primary outcome is the main question the study is designed to answer.
dexmedetomidine treat supraventricular tachycardia
effective rate of dexmedetomidine on supraventricular tachycardia
Measured: through study completion, up to 6 months
midazolam treat supraventricular tachycardia
effective rate of midazolam on supraventricular tachycardia
Measured: 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
Measured: through study completion, up to 6 months
Secondary outcomes (7)
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
Measured: through study completion, up to 6 months
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
Measured: through study completion, up to 6 months
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
Measured: through study completion, up to 6 months
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
Measured: through study completion, up to 6 months
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
Measured: through study completion, up to 6 months
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
Measured: through study completion, up to 6 months
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
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start26 Feb 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perioperative PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients with supraventricular tachycardia
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lianyungang Hospital Affiliated Bengbu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junlong Zhang, PhD, Principal investigator, the Affiliated Lianyungang No. 2 People's Hospital of Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284150
- Sponsor's protocol ID
- 2019101201
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29025197Zhu 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.
PubMed 31168973Black 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.
PubMed 30170229Jung 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.
PubMed 31671483Chrysostomou 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.
PubMed 22613357Liu 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.
PubMed 27654700
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine During the Perioperative Period
- ClinicalTrials.gov ID
- NCT04284150
- Acronym / sponsor ID
- 2019101201
- Conditions
- Perioperative Period
- Keywords
- Supraventricular tachycardia, Dexmedetomidine, Midazolam, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lianyungang Hospital Affiliated Bengbu Medical CollegeUniversity, hospital or other
- Study start
- 26 Feb 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with supraventricular tachycardia
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine or Midazola treat supraventricular tachycardia | Experimental | Drug: Dexmedetomidine; Midazolam;Comparison of efficacy of dexmedetomidine and Midazolam in the treatment of SVT |
Who may qualify
- Ages
- 35 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with supraventricular tachycardia
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine; Midazolam;Also: supraventricular tachycardiaTreatment of supraventricular tachycardia in patients with non-cardiac surgery by dexmedetomidine during the perioperative period | Drug | dexmedetomidine or Midazola treat supraventricular tachycardia |
Primary outcome
dexmedetomidine treat supraventricular tachycardia
Time frame: through study completion, up to 6 months
effective rate of dexmedetomidine on supraventricular tachycardia
midazolam treat supraventricular tachycardia
Time frame: through study completion, up to 6 months
effective rate of midazolam on supraventricular tachycardia
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
7 secondary outcomes
alarm/sedation (OAA/S) score
Time frame: through study completion, up to 6 months
heart rate (HR)
Time frame: through study completion, up to 6 months
mean arterial pressure (MAP)
Time frame: through study completion, up to 6 months
pulse oxygen saturation (SpO2)
Time frame: through study completion, up to 6 months
normalized low frequency power
Time frame: through study completion, up to 6 months
normalized high frequency power
Time frame: through study completion, up to 6 months
the balance ratio of sympathetic to vagal tone
Time frame: through study completion, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Results publication: PubMed 29025197Alabed 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 publication: PubMed 31168973Zhu 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 publication: PubMed 30170229Black 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 publication: PubMed 31671483Jung 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 publication: PubMed 22613357Chrysostomou 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 publication: PubMed 27654700Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junlong Zhang, PhD principal investigator
the Affiliated Lianyungang No. 2 People's Hospital of Jiangsu University
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine; Midazolam; in people with Perioperative Period, run by Lianyungang Hospital Affiliated Bengbu Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junlong Zhang, PhD (15715139688, zjlddqzyw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dexmedetomidine treat supraventricular tachycardia (time frame: through study completion, up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04284150, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.