Surgical PatientsNCT01355432
Heart Rate Changes With Propofol
An observational study of Surgical Patients, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Surgical Patients
- What is being tested?
- Observation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2012
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgery patients at Nationwide Children's Hospital.
Who may be able to join
- At least 1 year of age or older.
- Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).
- Patients that are already scheduled to receive inhalational induction followed by IV propofol.
Who cannot join
- 1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Changes in Heart Rate Following Administration of Propofol After Inhalational Induction
This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.
- Conditions
- Surgical Patients
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
There is no intervention, this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Measured: Baseline & every 30 secs for 3 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical PatientsStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Lancaster, Nationwide Children's Hospital
- Investigators
- Christopher Lancaster, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355432
- Sponsor's protocol ID
- IRB11-00236
- Status last verified
- May 2012
- First submitted
- 17 May 2011
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Heart Rate Following Administration of Propofol After Inhalational Induction
- ClinicalTrials.gov ID
- NCT01355432
- Acronym / sponsor ID
- IRB11-00236
- Conditions
- Surgical Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 May 2011 (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 prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | – | Other: Observation |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgery patients at Nationwide Children's Hospital.
Key inclusion criteria (3 listed)
- At least 1 year of age or older.
- Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).
- Patients that are already scheduled to receive inhalational induction followed by IV propofol.
Key exclusion criteria (1 listed)
- 1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.
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 |
|---|---|---|
| ObservationThere is no intervention, this is an observational study. | Other | Propofol |
Primary outcome
Change in heart rate
Time frame: Baseline & every 30 secs for 3 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 2 May 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.
Christopher Lancaster, 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 Surgical Patients, run by Nationwide Children's Hospital 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 3 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 2 May 2012. 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 heart rate (time frame: Baseline & every 30 secs for 3 mins). 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 2 May 2012.