Slow Propofol Administration for Low Blood Pressure

Phase 3

Waitlist Available

Led By Nitin Goyal

Research Sponsored by University of Toledo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

duration of the surgery longer than one hour

patient undergoing non-cardiac elective surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate post-op to 30 days post operatively

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if giving Propofol more slowly can reduce side effects like sudden blood pressure changes. The study focuses on patients who need Propofol for medical procedures. By administering it slowly, researchers hope to see fewer blood pressure issues and less need for extra medications.

Who is the study for?

This trial is for patients aged 18-80 undergoing non-cardiac elective surgery lasting over an hour, who speak English fluently. They must be planned to receive Propofol as the main anesthesia for induction by their anesthesiologist.

What is being tested?

The study aims to see if giving Propofol slowly leads to fewer blood pressure drops compared to the standard speed of administration. It will also look at whether less medication is needed to correct blood pressure when it's given slowly.

What are the potential side effects?

Propofol may cause low blood pressure, which this study specifically investigates. The side effects might include a temporary drop in blood pressure during and immediately after its administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My surgery is expected to last more than an hour.

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I am scheduled for a planned surgery that is not on my heart.

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My anesthesiologist plans to use Propofol for my surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate post-op to 30 days post operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate post-op to 30 days post operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate post-op to 30 days post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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.