Hypotension on InductionPhase 3NCT05415436

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

A Phase 3 study testing Propofol slow administration in people with Hypotension on Induction, run by University of Toledo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Hypotension on Induction
What is being tested?: Propofol slow administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 11 Aug 2022to 21 Jul 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Toledo Medical Center
Toledo, Ohio, 43614

Other trials in United States

About this study

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

Conditions: Hypotension on Induction
Being tested: Propofol slow administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Propofol slow administrationOther
Propofol will be slowly administered over 120 seconds by anesthesia provider

Study groups in NCT05415436
Study group	Role	What they receive
Group A- propofol given at FDA approved administration speed	No intervention	Not described
Group B- propofol given over 120 seconds	Experimental	Not described Receives: Other: Propofol slow administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: induction to 1 hour post induction

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.
We will collect the patient's blood pressure post-operatively and length of hospital stay and compare.
Measured: immediate post-op to 30 days post operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 202221 Jul 2023

First posted13 Jun 2022
Study start11 Aug 2022
Primary completion30 Jun 2023
Study completion21 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypotension on InductionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05415436
Sponsor's protocol ID: Propofol study
Status last verified: Dec 2024
First submitted: 20 Apr 2022
Last updated: 21 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypotension on Induction trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analyzing the Relationship Between Rate of Induction and Perioperative Hypotension Using Propofol
ClinicalTrials.gov ID: NCT05415436
Acronym / sponsor ID: Propofol study
Conditions: Hypotension on Induction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of ToledoUniversity, hospital or other
Study start: 11 Aug 2022 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 21 Jul 2023 (actual)
First posted: 13 Jun 2022 (actual)
Results: Posted 21 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A- propofol given at FDA approved administration speed	No intervention	–
Group B- propofol given over 120 seconds	Experimental	Other: Propofol slow administration

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Propofol slow administrationPropofol will be slowly administered over 120 seconds by anesthesia provider	Other	Group B- propofol given over 120 seconds

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 21 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A- Propofol Given at FDA Approved Administration Speed	54	52
Group B- Propofol Given Over 120 Seconds	46	46

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Group A- Propofol Given at FDA Approved Administration Speed n = 53	Group B- Propofol Given Over 120 Seconds n = 46
Number of participants with post induction hypotension	4	2
Number of participants without post induction hypotension	49	44

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data was collected from date of enrollment in the study, which was the patient's procedure date, to 30 days post-operatively.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A- Propofol Given at FDA Approved Administration Speed	1 of 53 (1.9%)	0 of 53 (0%)	1 of 53
Group B- Propofol Given Over 120 Seconds	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypotension on Induction

Not yet recruiting
Pre-induction Norepinephrine in Septic Patients Undergoing Surgery
Sepsis, Hypotension
Not yet recruiting
Frequency of Electrical Acupoint Stimulation on Hypotension During Induction
Anesthesia, Post-induction Hypotension (PIH)
RecruitingObservational study
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
Intraoperative Hypotension, Jugular Veins
RecruitingObservational study
A Study of Changes in Heart Function and Blood Flow in People Receiving Anesthesia
Anesthesia
Recruiting
5 Versus 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery
Hypotension on Induction, Emergency Surgery

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Pappada, PhD principal investigator

University of Toledo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Propofol slow administration in people with Hypotension on Induction, run by University of Toledo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05415436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.