Cardiac ArrhythmiaNCT01652586
Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
A study testing dexmedetomidine-remifentanil and midazolam-remifentanil in people with Cardiac Arrhythmia, run by Yonsei University.
Trial summary
Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- dexmedetomidine-remifentanil and midazolam-remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Dec 2011
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective cardiac ablation for atrial fibrillation
Who cannot join
- ASA physical status class ≥ 3,
- respiratory disease,
- end stage renal disease,
- illiterate
About this study
Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. The aim of this study was to compare the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect without serious respiratory depression, with conventional midazolam/remifentanil combination on sedative and analgesic levels in patients undergoing endocardial ablation.
- Conditions
- Cardiac Arrhythmia
- Being tested
- dexmedetomidine-remifentanil, midazolam-remifentanil
- Keywords
- cardiac ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine-remifentanilDrug
midazolam-remifentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine-remifentanil | Experimental | intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min Receives: Drug: dexmedetomidine-remifentanil |
| midazolam-remifentanil | Active comparator | remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg Receives: Drug: midazolam-remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of sedation depth
- Ramsay sedation score (1 = anxious and agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responsive to verbal commands, drowsy; 4 = asleep, responsive to light stimulation; 5 = asleep, slow response to stimulation; 6 = no response to stimulation)
- the bispectral index
Measured: 5 min after study drug adminstration, and every 10 min thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Lan Kwak, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652586
- Sponsor's protocol ID
- 1-2011-0008
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
- ClinicalTrials.gov ID
- NCT01652586
- Acronym / sponsor ID
- 1-2011-0008
- Conditions
- Cardiac Arrhythmia
- Keywords
- cardiac ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jul 2012 (estimated)
- 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.
Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. The aim of this study was to compare the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect without serious respiratory depression, with conventional midazolam/remifentanil combination on sedative and analgesic levels in patients undergoing endocardial ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine-remifentanil | Experimental | Drug: dexmedetomidine-remifentanilintravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min |
| midazolam-remifentanil | Active comparator | Drug: midazolam-remifentanilremifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for elective cardiac ablation for atrial fibrillation
Key exclusion criteria (4 listed)
- ASA physical status class ≥ 3,
- respiratory disease,
- end stage renal disease,
- illiterate
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-remifentanil | Drug | dexmedetomidine-remifentanil |
| midazolam-remifentanil | Drug | midazolam-remifentanil |
Primary outcome
change of sedation depth
Time frame: 5 min after study drug adminstration, and every 10 min thereafter
1. Ramsay sedation score (1 = anxious and agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responsive to verbal commands, drowsy; 4 = asleep, responsive to light stimulation; 5 = asleep, slow response to stimulation; 6 = no response to stimulation) 2. the bispectral index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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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.
Young Lan Kwak, MD, PhD principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine-remifentanil and midazolam-remifentanil in people with Cardiac Arrhythmia, run by Yonsei University.
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 4 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: finished, as of the sponsor's last update on 30 Jul 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of sedation depth (time frame: 5 min after study drug adminstration, and every 10 min thereafter). 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 30 Jul 2012.