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

NCT05415436 | Completed Phase 3 Results FDA Drug

• 1 other identifier: Propofol study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension on Induction

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  immediate post-op to 30 days post operatively

Study Arms (2)

Group A- propofol given at FDA approved administration speed

NO INTERVENTION

Group B- propofol given over 120 seconds

EXPERIMENTAL

Other: Propofol slow administration

Interventions

Propofol slow administration OTHER

Propofol will be slowly administered over 120 seconds by anesthesia provider

Group B- propofol given over 120 seconds

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toledo: lead

Study Sites (1)

The University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Results Point of Contact

• Title: Kristi Baker BSN, RN
• Organization: The University of Toledo Medical Center

kristi.baker@utoledo.edu

4193836223

Study Officials

• Scott Pappada, PhD

  University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: June 13, 2022
• Study Start: August 11, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 21, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)