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The Hypotensive Effect of Propofol: an Observational Study

This study is not yet open for participant recruitment.
Verified January 2012 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Thomas Verbeek, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01508351
First received: January 9, 2012
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Hypotension
Anesthesia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • The systolic, diastolic, and mean arterial pressure. [ Time Frame: Within first 20 minutes after anesthesia induction ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Propofol Induction
All patients receiving propofol induction of anesthesia who are ASA 1-3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hershey Medical Center patients presenting for surgery.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508351

Contacts
Contact: Thomas A Verbeek, MBChB (717) 531 5167 tverbeek@hmc.psu.edu
Contact: Daniel R Tapia, MD (717) 531 5167 dtapia@hmc.psu.edu

Locations
United States, Pennsylvania
Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Thomas A Verbeek, MBChB            
Sponsors and Collaborators
Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Thomas Verbeek, Assistant Professor, Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01508351     History of Changes
Other Study ID Numbers: 38444
Study First Received: January 9, 2012
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Propofol
Induction
Hypotension
General population

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

ClinicalTrials.gov processed this record on May 23, 2013