Heart Rate Changes With Propofol | NCT01355432

Studies
Heart Rate Changes With Propofol

NCT01355432

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

May 2, 2012Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Surgical Patients

Interventions

Observation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 17, 2011

First Posted Date

May 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2012

Last Update Posted Date

May 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Lancaster, Attending Anesthesiologist, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol			Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	There is no intervention, this is an observational study.	Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in heart rate		Baseline & every 30 secs for 3 mins

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Surgery patients at Nationwide Children's Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Lancaster, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided