- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355432
Heart Rate Changes With Propofol
May 1, 2012 updated by: Christopher Lancaster, Nationwide Children's Hospital
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Surgery patients at Nationwide Children's Hospital.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Propofol
|
There is no intervention, this is an observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in heart rate
Time Frame: Baseline & every 30 secs for 3 mins
|
Baseline & every 30 secs for 3 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Lancaster, MD, Nationwide Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Estimate)
May 2, 2012
Last Update Submitted That Met QC Criteria
May 1, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- IRB11-00236
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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