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General Anesthetic

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.
Select...
I am scheduled for a planned surgery that is not on my heart.
Select...
My anesthesiologist plans to use Propofol for my surgery.

Timeline

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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group B- propofol given over 120 secondsExperimental Treatment1 Intervention
Group II: Group A- propofol given at FDA approved administration speedActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of ToledoLead Sponsor
7 Previous Clinical Trials
538 Total Patients Enrolled
Nitin GoyalPrincipal InvestigatorUniversity of Toledo
Tanaya SparklePrincipal InvestigatorUniversity of Toledo
~32 spots leftby Oct 2025
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