Heart Rate Changes With Propofol

Surgical Patients Clinical Trial

Official title:

Changes in Heart Rate Following Administration of Propofol After Inhalational Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355432
• Other study ID #: IRB11-00236
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: May 1, 2012
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Patients

Intervention

Other:
• Observation
There is no intervention, this is an observational study.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate		Baseline & every 30 secs for 3 mins	No