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

Hypotension on Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05415436
• Other study ID #: Propofol study
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 11, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: University of Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension on Induction

Intervention

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

Locations

Country	Name	City	State
United States	The University of Toledo Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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