The Hypotensive Effect of Propofol: an Observational Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Milton S. Hershey Medical Center.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014