Heart Rate Changes With Propofol
This study has been completed.
Sponsor:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Christopher Lancaster, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01355432
First received: May 17, 2011
Last updated: May 1, 2012
Last verified: May 2012
| Tracking Information | |||||
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| First Received Date ICMJE | May 17, 2011 | ||||
| Last Updated Date | May 1, 2012 | ||||
| Start Date ICMJE | May 2011 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in heart rate [ Time Frame: Baseline & every 30 secs for 3 mins ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01355432 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Heart Rate Changes With Propofol | ||||
| Official Title ICMJE | Changes in Heart Rate Following Administration of Propofol After Inhalational Induction | ||||
| Brief Summary | This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Surgery patients at Nationwide Children's Hospital. |
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| Condition ICMJE | Surgical Patients | ||||
| Intervention ICMJE | Other: Observation
There is no intervention, this is an observational study. |
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| Study Group/Cohort (s) | Propofol
Intervention: Other: Observation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | May 2012 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study. |
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| Gender | Both | ||||
| Ages | 1 Year and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01355432 | ||||
| Other Study ID Numbers ICMJE | IRB11-00236 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christopher Lancaster, Nationwide Children's Hospital | ||||
| Study Sponsor ICMJE | Nationwide Children's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nationwide Children's Hospital | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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