The Hypotensive Effect of Propofol: an Observational Study

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508351
• Other study ID #: 38444
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: April 28, 2015
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Hypotension

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes