Analyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure

Overview

The objective of this study is to evaluate the hemodynamic changes related to Propofol administration rate. We hypothesize that slow administration of IV propofol will have less hemodynamic disturbances and will require less amount of vasoactive medication for BP correction when compared to standard FDA approved administration rate.

Full Title of Study: “Analyzing the Relationship Between Rate of Induction and Perioperative Hypotension Using Propofol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2022

Interventions

  • Other: Propofol slow administration
    • Propofol will be slowly administered over 120 seconds by anesthesia provider

Arms, Groups and Cohorts

  • No Intervention: Group A- propofol given at FDA approved administration speed
  • Experimental: Group B- propofol given over 120 seconds

Clinical Trial Outcome Measures

Primary Measures

  • Patients administered Propofol at a slower rate of infusion will have lower incidence of post induction hypotension than patients administered Propofol at FDA approved rate.
    • Time Frame: induction to 1 hour post induction
    • We will collect the patient’s blood pressure intra-operatively every 5 minutes starting on induction up to one hour after induction and compare.

Secondary Measures

  • Patients administered Propofol at a slower rate will have less complications during the early post-op period than patients administered Propofol at FDA approved rate.
    • Time Frame: immediate post-op to 30 days post operatively
    • We will collect the patient’s blood pressure post-operatively and length of hospital stay and compare.

Participating in This Clinical Trial

Inclusion Criteria

  • any patient from 18 till 80 years of age – patient undergoing non-cardiac elective surgery – duration of the surgery longer than one hour – native/fluent English speaker – patients whose staff anesthesiologist planned to use Propofol as a primary anesthetic for induction Exclusion Criteria:

  • any patient admitted for non-elective surgery – any patient undergoing cardiac surgery – any patient under 18 years of age – any patient older than 80 years of age – any patient with history of severe heart disease (CHF with significant limitations of activity due to sever symptoms, prior heart surgery, atrial fibrillation, etc.) – any patient with pre-operative hemodynamic instability (e.g. sepsis, chronic kidney disease, liver cirrhosis) who requires constant or intermittent administration of vasoactive or inotropic medication to support vital signs (BP) – any patient on vasoactive or inotrop medications in early pre-operative period (within 24 hours prior to the surgery) – any patient who does not speak English or not fluently – any patient with cognitive impairment or mentally incapacitation – any pregnant or breastfeeding females – any patient whose staff anesthesiologist planned to use a primary anesthetic other than Propofol

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Toledo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tanaya Sparkle, Principal Investigator, University of Toledo
  • Overall Contact(s)
    • Tanaya Sparkle, MD, 419-383-3556, tanaya.sparkle@utoledo.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.