NCT01355432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

May 17, 2011

Last Update Submit

May 1, 2012

Conditions

Surgical Patients

Outcome Measures

Primary Outcomes (1)

  • Change in heart rate

    Baseline & every 30 secs for 3 mins

Study Arms (1)

Propofol

Other: Observation

Interventions

ObservationOTHER

There is no intervention, this is an observational study.

Propofol

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgery patients at Nationwide Children's Hospital.

You may qualify if:

  • At least 1 year of age or older.
  • Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).
  • Patients that are already scheduled to receive inhalational induction followed by IV propofol.

You may not qualify if:

  • \. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Christopher Lancaster, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 18, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations

US(1)