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

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • 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:

  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.

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
Other: Observation
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

Nationwide Children's Hospital

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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