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Completed

NCT Number: NCT05415436

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

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.

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Key information

Conditions

Hypotension on Induction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol slow administration

Other

Propofol will be slowly administered over 120 seconds by anesthesia provider

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Toledo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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