The Hypotensive Effect of Propofol: an Observational Study | NCT01508351

Studies
The Hypotensive Effect of Propofol: an Observational Study

NCT01508351

Sponsor

Milton S. Hershey Medical Center

Status

Completed

Last Update Posted

Apr 29, 2015Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Hypotension
Anesthesia

Interventions

Not provided

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

Apr 2015

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 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 11, 2012Estimated

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

Apr 28, 2015

Last Update Posted Date

Apr 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Verbeek, Assistant Professor, Anesthesiology, Milton S. Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

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

Hypotension is a recognized frequent complication of induction of anesthesia. The intent of this research is to determine the incidence of hypotension in patients receiving anesthetic induction with propofol. This investigation seeks to examine how normal clinical practice or a "real world" understanding of the usual response to propofol affects hemodynamics without isolating or standardizing other variables. The current research concerns hypotension in normal clinical practice where variability exists. This project aims to gather information and data in an attempt to form a foundation upon which each of the other variables affecting blood pressure may be subsequently assessed.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol Induction		All patients receiving propofol induction of anesthesia who are ASA 1-3

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The systolic, diastolic, and mean arterial pressure.	The systolic, diastolic, and mean arterial pressure will be measured every minute for twenty minutes. Blood pressure readings of Mean Arterial Pressure less than 65mmHg, Systolic Blood Pressure less than 80mmHg, or Diastolic Blood Pressure less than 40mmHg will be considered as hypotension.	Within first 20 minutes after anesthesia induction

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All ASA 1-3 patients who are to receive propofol induction for general anesthesia

Exclusion Criteria:

Allergy to propofol
ASA 4 and above

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hershey Medical Center patients presenting for surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milton S. Hershey Medical Center		Hershey	Pennsylvania	17033	United States

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided