Heart Rate Changes With Propofol

This study has been completed.
Sponsor:
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
  Purpose

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


Condition Intervention
Surgical Patients
Other: Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Heart Rate Following Administration of Propofol After Inhalational Induction

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Change in heart rate [ Time Frame: Baseline & every 30 secs for 3 mins ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Propofol Other: Observation
There is no intervention, this is an observational study.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Christopher Lancaster, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01355432     History of Changes
Other Study ID Numbers: IRB11-00236
Study First Received: May 17, 2011
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014