SurgeryNCT01917786
Effect of Dexmedetomidine on QT Interval in Pediatric Patients Under General Anesthesia
An observational study of Surgery, run by Senthil G. Krishna at 1 site in United States.
Trial summary
Various medications used in anesthesia have been implicated in the prolongation of QT interval. Recently, there has been an increase in the use of dexmedetomidine in patients presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- ECG
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving dexmedetomidine as part of their surgical anesthesia.
Who may be able to join
- ASA grade 1 or 2.
- Scheduled to receive dexmedetomidine.
Who cannot join
- Known allergy to dexmedetomidine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Various medications used in anesthesia have been implicated in the prolongation of QT interval. Recently, there has been an increase in the use of dexmedetomidine in patients presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties. It has several desirable properties including minimal respiratory side effects as well as the ability to decrease intraoperative and postoperative analgesic requirements. In many of the patients who present for routine surgical procedures, dexmedetomidine is a common component of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT interval in children presenting for surgery.
- Conditions
- Surgery
- Being tested
- ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDevice
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine patients | Surgical patients receiving dexmedetomidine. Receives: Device: ECG | |
| Control patients | Surgical patients not receiving dexmedetomidine. Receives: Device: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT interval
ECG will be done to assess QT interval prior to induction (baseline), after induction (5 mins.) and after dexmedetomidine (10 mins.)
Measured: Baseline, 5 mins., 10 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senthil G. Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senthil G. Krishna, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917786
- Sponsor's protocol ID
- IRB13-00171
- Status last verified
- Jan 2016
- First submitted
- 25 Jun 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kako H, Krishna SG, Sebastian R, Smith K, Tobias JD. Effect of dexmedetomidine on the QT interval in pediatric patients undergoing general anesthesia. J Anesth. 2015 Dec;29(6):862-7. doi: 10.1007/s00540-015-2056-2. Epub 2015 Aug 4.
PubMed 26238761
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on QT Interval in Pediatric Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01917786
- Acronym / sponsor ID
- IRB13-00171
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Senthil G. KrishnaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Aug 2013 (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.
Various medications used in anesthesia have been implicated in the prolongation of QT interval. Recently, there has been an increase in the use of dexmedetomidine in patients presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties. It has several desirable properties including minimal respiratory side effects as well as the ability to decrease intraoperative and postoperative analgesic requirements. In many of the patients who present for routine surgical procedures, dexmedetomidine is a common component of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT interval in children presenting for surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine patients | – | Device: ECGSurgical patients receiving dexmedetomidine. |
| Control patients | – | Device: ECGSurgical patients not receiving dexmedetomidine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving dexmedetomidine as part of their surgical anesthesia.
Key inclusion criteria (2 listed)
- ASA grade 1 or 2.
- Scheduled to receive dexmedetomidine.
Key exclusion criteria (1 listed)
- Known allergy to dexmedetomidine.
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 |
|---|---|---|
| ECG | Device | Control patients, Dexmedetomidine patients |
Primary outcome
Change in QT interval
Time frame: Baseline, 5 mins., 10 mins.
ECG will be done to assess QT interval prior to induction (baseline), after induction (5 mins.) and after dexmedetomidine (10 mins.)
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 8 Jan 2016.
- Derived from this study: PubMed 26238761Kako H, Krishna SG, Sebastian R, Smith K, Tobias JD. Effect of dexmedetomidine on the QT interval in pediatric patients undergoing general anesthesia. J Anesth. 2015 Dec;29(6):862-7. doi: 10.1007/s00540-015-2056-2. Epub 2015 Aug 4.
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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?
An observational study of Surgery, run by Senthil G. Krishna at 1 site in United States.
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 2 inclusion and 1 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 8 Jan 2016. 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 United States. 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 in QT interval (time frame: Baseline, 5 mins., 10 mins.). 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 NCT01917786, which also lists 1 linked publication.
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 8 Jan 2016.