TonsillectomyNCT01917097
Bradycardia Following Intraoperative Administration of Dexmedetomidine
An observational study of Tonsillectomy and Adenotonsillectomy, run by Joseph D. Tobias at 1 site in United States.
Trial summary
This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillectomy, Adenotonsillectomy
- What is being tested?
- Dexmedetomidine
- How many people
- 921 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2016
- 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 having ENT surgery at Nationwide Children's Hospital.
Who may be able to join
- Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may be precipitating the bradycardia or potentiating the negative chronotropic effects of dexmedetomidine.
- Conditions
- Tonsillectomy, Adenotonsillectomy
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine patients | Patients that received dexmedetomidine during their surgery. Receives: Drug: Dexmedetomidine | |
| No Dexmedetomidine | Patients that didn't receive dexmedetomidine during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradycardia
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 posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917097
- Sponsor's protocol ID
- IRB13-00524
- Status last verified
- Oct 2016
- First submitted
- 2 Aug 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bradycardia Following Intraoperative Administration of Dexmedetomidine
- ClinicalTrials.gov ID
- NCT01917097
- Acronym / sponsor ID
- IRB13-00524
- Conditions
- Tonsillectomy, Adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 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.
This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may be precipitating the bradycardia or potentiating the negative chronotropic effects of dexmedetomidine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine patients | – | Drug: DexmedetomidinePatients that received dexmedetomidine during their surgery. |
| No Dexmedetomidine | – | –Patients that didn't receive dexmedetomidine during surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients having ENT surgery at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex | Drug | Dexmedetomidine patients |
Primary outcome
Bradycardia
Time frame: 24 hours
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 27 Oct 2016.
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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.
Joseph D Tobias, MD principal investigator
Nationwide Children's Hospital
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 Tonsillectomy and Adenotonsillectomy, run by Joseph D. Tobias 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 1 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 27 Oct 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?
Bradycardia (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 27 Oct 2016.