NCT05415436

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

Completed Phase 3 Results posted Last updated 21 March 2025

What this trial tests

Phase 3 trial testing Propofol slow administration in Hypotension on Induction in 100 participants. Completed in 21 July 2023.

Timeline

11 August 2022

Primary endpoint
30 June 2023

21 July 2023

Quick facts

Lead sponsor	University of Toledo
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	100
Start date	11 August 2022
Primary completion	30 June 2023
Estimated completion	21 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Propofol slow administration

Conditions studied

• Hypotension on Induction — all drugs for Hypotension on Induction →

Sponsor

University of Toledo

Who can join

Adults 18 to 80, any sex, with Hypotension on Induction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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.

Number of participants with post induction hypotension

Group	Value	95% CI
Group A- Propofol Given at FDA Approved Administration Speed	4
Group B- Propofol Given Over 120 Seconds	2

Number of participants without post induction hypotension

Group	Value	95% CI
Group A- Propofol Given at FDA Approved Administration Speed	49
Group B- Propofol Given Over 120 Seconds	44

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. Secondary · 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.

Participants requiring albumin administration

Group	Value	95% CI
Group A- Propofol Given at FDA Approved Administration Speed	4
Group B- Propofol Given Over 120 Seconds	0

Participants requiring vasopressin administration

Group	Value	95% CI
Group A- Propofol Given at FDA Approved Administration Speed	4
Group B- Propofol Given Over 120 Seconds	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected from date of enrollment in the study, which was the patient's procedure date, to 30 days post-operatively.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A- Propofol Given at FDA Approved Administration Speed

Serious: 1/53 (2%)

Deaths: 1/53

Group B- Propofol Given Over 120 Seconds

Serious: 0/46 (0%)

Deaths: 0/46

Serious adverse events (1 terms)

Reaction	System	Group A- Propofol Given at…	Group B- Propofol Given Ov…
participant died 5 days post study procedure due to multi system organ failure	Vascular disorders	—	—

Most-reported serious reactions: participant died 5 days post study procedure due to multi system organ failure.

Data from ClinicalTrials.gov NCT05415436 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.