Anesthesia, GeneralNCT01584570
The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval
A study testing 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min in people with Anesthesia, General, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2012to 23 Dec 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient who are regarded as ASA class I
- age 20 to 60
- patient scheduled for Intubation for surgery
Who cannot join
- QTc interval > 440 ms
- arrythmia
- Patient who is taking a medicine which effects QTc interval
- HTN
- DM
- renal disease
Show all 9Show fewer
- hepatic disease
- pregnant
- illiterate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.
- Conditions
- Anesthesia, General
- Being tested
- 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min
- Keywords
- dexmedetomidine, heart rate variability, QTc interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 minDrug
ECG monitoring for evaluation of QTc interval
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | fentanyl 1 mcg/kg before induction Receives: Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min |
| D 0.5 group | Experimental | Dexmedetomidine 0.5 ug/kg + Propofol + Sevoflurane+ Vecuronium Receives: Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min |
| D 1.0 group | Experimental | Dexmedetomidine 1.0 ug/kg + Propofol + Sevoflurane+ Vecuronium Receives: Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of QTc interval
T1- baseline, T2- to evaluate the effect of dexmedetomidine on QTc interval, T3- to evaluate QTc interval just before intubation, T4,5,6 - to evaluate QTc interval after intubation
Measured: T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study start1 Jan 2012
- Primary completion23 Dec 2013
- Study completion23 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584570
- Sponsor's protocol ID
- 4-2011-0791
- Status last verified
- Feb 2019
- First submitted
- 20 Apr 2012
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval
- ClinicalTrials.gov ID
- NCT01584570
- Acronym / sponsor ID
- 4-2011-0791
- Conditions
- Anesthesia, General
- Keywords
- dexmedetomidine, heart rate variability, QTc interval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012
- Primary completion
- 23 Dec 2013 (actual)
- Study completion
- 23 Dec 2013 (actual)
- First posted
- 25 Apr 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.
The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 minfentanyl 1 mcg/kg before induction |
| D 0.5 group | Experimental | Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 minDexmedetomidine 0.5 ug/kg + Propofol + Sevoflurane+ Vecuronium |
| D 1.0 group | Experimental | Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 minDexmedetomidine 1.0 ug/kg + Propofol + Sevoflurane+ Vecuronium |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patient who are regarded as ASA class I
- age 20 to 60
- patient scheduled for Intubation for surgery
Key exclusion criteria (9 listed)
- QTc interval > 440 ms
- arrythmia
- Patient who is taking a medicine which effects QTc interval
- HTN
- DM
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 |
|---|---|---|
| 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 minECG monitoring for evaluation of QTc interval | Drug | Control, D 0.5 group, D 1.0 group |
Primary outcome
Change of QTc interval
Time frame: T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)
T1- baseline, T2- to evaluate the effect of dexmedetomidine on QTc interval, T3- to evaluate QTc interval just before intubation, T4,5,6 - to evaluate QTc interval after intubation
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 26 Feb 2019.
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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.
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 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min in people with Anesthesia, General, run by Yonsei University at 1 site in South Korea.
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 9 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 26 Feb 2019. 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 South Korea. 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?
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 QTc interval (time frame: T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)). 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 26 Feb 2019.