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The Hypotensive Effect of Propofol: an Observational Study

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ClinicalTrials.gov Identifier: NCT01508351
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : April 29, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Hypotension Anesthesia

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Hypotensive Effect of Propofol: an Observational Study of Hypotension With Anesthetic Induction by Propofol in the General Population Under Standard of Care Anesthesia
Study Start Date : May 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Groups and Cohorts

Propofol Induction
All patients receiving propofol induction of anesthesia who are ASA 1-3

Outcome Measures

Primary Outcome Measures :
  1. The systolic, diastolic, and mean arterial pressure. [ Time Frame: Within first 20 minutes after anesthesia induction ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hershey Medical Center patients presenting for surgery.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508351

United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
More Information

Responsible Party: Thomas Verbeek, Assistant Professor, Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01508351     History of Changes
Other Study ID Numbers: 38444
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Thomas Verbeek, Milton S. Hershey Medical Center:
General population

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General