Phase 3 N=100 Randomized Other

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

Hypotension on Induction

Bottom Line

View on ClinicalTrials.gov: NCT05415436 ↗

Enrolled (actual)

100

Serious AEs

1.0%

Results posted

Mar 2025

Primary outcome: 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. — 4; 2; 49; 44 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Propofol slow administration (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Toledo
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
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.	4; 2; 49; 44	—
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.	4; 0; 4; 0	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT05415436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.