Effect of Sedation on Heart Rate VariabilityNCT03601091
EFFECT OF DEXMEDETOMİDİNE AND MİDAZOLAM SEDATİON ON HEART RATE VARİABİLİTY AFTER CORONARY ARTERY BYPASS GRAFT SURGERY
A study testing Precedex 200 MCG in 2 ML Injection and DORMICUM 5MG/5 ML in people with Effect of Sedation on Heart Rate Variability, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The parasympathetic tone reduction and sympathetic tone enhancement, which are components of the autonomic nervous system (ANS) activity, increase the likelihood of malignant arrhythmias leading to ventricular fibrillation. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Sedation on Heart Rate Variability
- What is being tested?
- Precedex 200 MCG in 2 ML Injection and DORMICUM 5MG/5 ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2018to 31 Dec 2021
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with pre-operative normal sinus rhythm
- Ejection fraction (EF)> 45% on echocardiography (echocardiography) examination
- 25 and 65 years of age will be included.
Who cannot join
- Atrial fibrillation , atrial flutter, supraventricular tachycardia , AV block, ventricular extrasystole
- Cardiopulmonary bypass have been reported in patients with diabetes mellitus (DM),
- Chronic obstructive pulmonary disease (COPD),
- Previous cerebrovascular event will be excluded from the study.
- Patients receiving high-dose inotropic drug support after surgery (inotropic score of> 10 in the first 24 hours) and
- Patients re-operated for bleeding revision will be removed from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RANDOMİZED,DOUBLE-BLİND TRİAL OF EFFECT OF DEXMEDETOMİDİNE AND MİDAZOLAM SEDATİON ON HEART RATE VARİABİLİTY AFTER CORONARY ARTERY BYPASS GRAFT SURGERY
The parasympathetic tone reduction and sympathetic tone enhancement, which are components of the autonomic nervous system (ANS) activity, increase the likelihood of malignant arrhythmias leading to ventricular fibrillation. Malignant arrhythmias are associated with high mortality and morbidity after coronary artery bypass graft (CABG) surgeries. Heart rate variability (HRV) is a physiological indicator of the effects of ANS activity on heart rate and is associated with a prognostic value for cardiac mortality. Dexmedetomidine has been shown to improve myocardial perfusion, reduce arrhythmia incidence, reduce inflammatory response, and reduce mortality in patients with coronary artery disease. The aim of this study investigate the effects of dexmedetomidine electrophysiologically on cardiac autonomic system by using HRV analysis for the purpose of sedation in patients who were followed up in the intensive care unit after coronary artery bypass graft surgery
Read the detailed description
Malignant arrhythmias are associated with high mortality and morbidity after coronary artery bypass graft (CABG) operations. Heart rate variability (HRV) is a physiological indicator of the effects of activity on heart ANS rate and has prognostic value for cardiac mortality. Spectral analysis of HRV can provide an assessment of adrenergic and cholinergic system activities during anesthesia. With the "power spectral" analysis of HRV, important clinical information can be obtained about the effects of anesthesia on the autonomic nervous system and the central nervous system. Decrease in HRV has a prognostic value for cardiac-induced mortality. The disease, which is transferred to intensive care unit (ICU) after CABG, is sedated with different medicines until the time of extubation. One commonly used sedative drug is deksmedetomidine, an α2 receptor agonist. Alpha 2 (α2) receptor agonist drugs reduce myocardial oxygen consumption and heart rate with sympatholytic properties. Therefore, deksmedetomidine can be safely and effectively used in patients undergoing cardiac surgery without pro-tachyarrhythmic and / or negative inotropic effects.In this study, it was aimed to investigate electrophysiologic effects of cardiac autonomic system by using HRV analysis in dexmedetomine and midazolam patients who underwent elective CABG and were used for sedation in the postoperative period.
- Being tested
- Precedex 200 MCG in 2 ML Injection, DORMICUM 5MG/5 ML
- Keywords
- dexmedetomidine, coronary artery bypass graft, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precedex 200 MCG in 2 ML InjectionDrug
Infusion therapy of the drug
DORMICUM 5MG/5 MLDrug
Infusion therapy of the drug
| Study group | Role | What they receive |
|---|---|---|
| PR | Active comparator | PRECEDEX 200 mcg 2 ml,0,3 mcg/kg/h, intravenous continue infusion, 4 hours. Receives: Drug: Precedex 200 MCG in 2 ML Injection |
| DO | Active comparator | DORMICUM 5MG/5 ML, 0,1 mg/kh/h, intravenous continue infusion for 4 hours Receives: Drug: DORMICUM 5MG/5 ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Low and high frequency of heart rate regarding with aritmia incidence
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start22 Mar 2018
- Primary completion1 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Sedation on Heart Rate VariabilityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMISED- DOUBLE BLINDED
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601091
- Sponsor's protocol ID
- 2018/3/53
- Status last verified
- May 2021
- First submitted
- 27 Jun 2018
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMİZED,DOUBLE-BLİND TRİAL OF EFFECT OF DEXMEDETOMİDİNE AND MİDAZOLAM SEDATİON ON HEART RATE VARİABİLİTY AFTER CORONARY ARTERY BYPASS GRAFT SURGERY
- ClinicalTrials.gov ID
- NCT03601091
- Acronym / sponsor ID
- 2018/3/53
- Keywords
- dexmedetomidine, coronary artery bypass graft, heart rate variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Jul 2018 (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.
The parasympathetic tone reduction and sympathetic tone enhancement, which are components of the autonomic nervous system (ANS) activity, increase the likelihood of malignant arrhythmias leading to ventricular fibrillation. Malignant arrhythmias are associated with high mortality and morbidity after coronary artery bypass graft (CABG) surgeries. Heart rate variability (HRV) is a physiological indicator of the effects of ANS activity on heart rate and is associated with a prognostic value for cardiac mortality. Dexmedetomidine has been shown to improve myocardial perfusion, reduce arrhythmia incidence, reduce inflammatory response, and reduce mortality in patients with coronary artery disease. The aim of this study investigate the effects of dexmedetomidine electrophysiologically on cardiac autonomic system by using HRV analysis for the purpose of sedation in patients who were followed up in the intensive care unit after coronary artery bypass graft surgery
Detailed description
Malignant arrhythmias are associated with high mortality and morbidity after coronary artery bypass graft (CABG) operations. Heart rate variability (HRV) is a physiological indicator of the effects of activity on heart ANS rate and has prognostic value for cardiac mortality. Spectral analysis of HRV can provide an assessment of adrenergic and cholinergic system activities during anesthesia. With the "power spectral" analysis of HRV, important clinical information can be obtained about the effects of anesthesia on the autonomic nervous system and the central nervous system. Decrease in HRV has a prognostic value for cardiac-induced mortality. The disease, which is transferred to intensive care unit (ICU) after CABG, is sedated with different medicines until the time of extubation. One commonly used sedative drug is deksmedetomidine, an α2 receptor agonist. Alpha 2 (α2) receptor agonist drugs reduce myocardial oxygen consumption and heart rate with sympatholytic properties. Therefore, deksmedetomidine can be safely and effectively used in patients undergoing cardiac surgery without pro-tachyarrhythmic and / or negative inotropic effects.In this study, it was aimed to investigate electrophysiologic effects of cardiac autonomic system by using HRV analysis in dexmedetomine and midazolam patients who underwent elective CABG and were used for sedation in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RANDOMISED- DOUBLE BLINDED
| Arm | Type | Receives |
|---|---|---|
| PR | Active comparator | Drug: Precedex 200 MCG in 2 ML InjectionPRECEDEX 200 mcg 2 ml,0,3 mcg/kg/h, intravenous continue infusion, 4 hours. |
| DO | Active comparator | Drug: DORMICUM 5MG/5 MLDORMICUM 5MG/5 ML, 0,1 mg/kh/h, intravenous continue infusion for 4 hours |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pre-operative normal sinus rhythm
- Ejection fraction (EF)> 45% on echocardiography (echocardiography) examination
- 25 and 65 years of age will be included.
Key exclusion criteria (6 listed)
- Atrial fibrillation , atrial flutter, supraventricular tachycardia , AV block, ventricular extrasystole
- Cardiopulmonary bypass have been reported in patients with diabetes mellitus (DM),
- Chronic obstructive pulmonary disease (COPD),
- Previous cerebrovascular event will be excluded from the study.
- Patients receiving high-dose inotropic drug support after surgery (inotropic score of> 10 in the first 24 hours) and
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 |
|---|---|---|
| Precedex 200 MCG in 2 ML InjectionInfusion therapy of the drug | Drug | PR |
| DORMICUM 5MG/5 MLInfusion therapy of the drug | Drug | DO |
Primary outcome
Heart rate variability
Time frame: 24 hours
Low and high frequency of heart rate regarding with aritmia incidence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precedex 200 MCG in 2 ML Injection and DORMICUM 5MG/5 ML in people with Effect of Sedation on Heart Rate Variability, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2021.