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

Phase 3
Completed
Conditions
Hypotension on Induction
Registration Number
NCT05415436
Lead Sponsor
University of Toledo
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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.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 Outcome Measures
NameTimeMethod
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.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.

Trial Locations

Locations (1)

The University of Toledo Medical Center

🇺🇸

Toledo, Ohio, United States

The University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
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