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Heart Rate Changes With Propofol

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ClinicalTrials.gov Identifier: NCT01355432
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : May 2, 2012
Sponsor:
Information provided by (Responsible Party):
Christopher Lancaster, Nationwide Children's Hospital

Brief Summary:
This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.

Condition or disease Intervention/treatment
Surgical Patients Other: Observation

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Heart Rate Following Administration of Propofol After Inhalational Induction
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Group/Cohort Intervention/treatment
Propofol Other: Observation
There is no intervention, this is an observational study.



Primary Outcome Measures :
  1. Change in heart rate [ Time Frame: Baseline & every 30 secs for 3 mins ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgery patients at Nationwide Children's Hospital.
Criteria

Inclusion Criteria:

  1. At least 1 year of age or older.
  2. Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).
  3. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355432


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Christopher Lancaster, MD Nationwide Children's Hospital

Responsible Party: Christopher Lancaster, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01355432     History of Changes
Other Study ID Numbers: IRB11-00236
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics