BradycardiaNCT03294018
Heart Rate Changes Following the Administration of Sugammadex
An observational study of Bradycardia, run by Joseph D. Tobias at 1 site in United States.
Trial summary
This a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. If bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bradycardia
- What is being tested?
- Recording heart rate changes
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 10 Jan 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.
Who may be able to join
- Patient age 0-18 years
- Anesthetic plan includes NMB reversal with sugammadex
Who cannot join
- Sugammadex not used during the case
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. If bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded.
- Conditions
- Bradycardia
- Being tested
- Recording heart rate changes
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording heart rate changesOther
Recording heart rate changes during planned sugammadex administration.
| Study group | Role | What they receive |
|---|---|---|
| Bradycardia during sugammadex administration | Recording any heart rate changes during planned administration of sugammadex. Receives: Other: Recording heart rate changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradycardia during sugammadex administration
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start6 Sep 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 276 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294018
- Sponsor's protocol ID
- IRB17-00540
- Status last verified
- Oct 2019
- First submitted
- 22 Sep 2017
- Last updated
- 9 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Changes Following the Administration of Sugammadex
- ClinicalTrials.gov ID
- NCT03294018
- Acronym / sponsor ID
- IRB17-00540
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 26 Sep 2017 (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.
This a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. If bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bradycardia during sugammadex administration | – | Other: Recording heart rate changesRecording any heart rate changes during planned administration of sugammadex. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female 0-18 years old undergoing surgery with anesthetic plan with sugammadex.
Key inclusion criteria (2 listed)
- Patient age 0-18 years
- Anesthetic plan includes NMB reversal with sugammadex
Key exclusion criteria (1 listed)
- Sugammadex not used during the case
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 |
|---|---|---|
| Recording heart rate changesRecording heart rate changes during planned sugammadex administration. | Other | Bradycardia during sugammadex administration |
Primary outcome
Bradycardia during sugammadex administration
Time frame: intraoperative
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 9 Oct 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?
An observational study of Bradycardia, 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 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 9 Oct 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 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 during sugammadex administration (time frame: intraoperative). 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 9 Oct 2019.