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

Analyzing the Relationship Between Rate of Induction and Perioperative Hypotension Using Propofol

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.

Study Overview

• Status: Recruiting
• Conditions: Hypotension on Induction
• Intervention / Treatment: Other: Propofol slow administration

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tanaya Sparkle, MD; Phone Number: 419-383-3556; Email: tanaya.sparkle@utoledo.edu
• Study Contact Backup: Name: Kristi Baker, RN; Phone Number: 419-383-6223; Email: kristi.baker@utoledo.edu

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • Recruiting
      • The University of Toledo Medical Center
      • Contact: Tanaya Sparkle, MD; Phone Number: 419-383-3556; Email: tanaya.sparkle@utoledo.edu
      • Contact: Kristi Baker, RN; Phone Number: 4193836223; Email: kristi.baker@utoledo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A- propofol given at FDA approved administration speed
Experimental: Group B- propofol given over 120 seconds	Other: Propofol slow administration; Propofol will be slowly administered over 120 seconds by anesthesia provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	We will collect the patient's blood pressure intra-operatively every 5 minutes starting on induction up to one hour after induction and compare.	induction to 1 hour post induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	We will collect the patient's blood pressure post-operatively and length of hospital stay and compare.	immediate post-op to 30 days post operatively

Collaborators and Investigators

• Sponsor: University of Toledo
• Investigators: Principal Investigator: Tanaya Sparkle, University of Toledo

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: Propofol study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes