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

NCT ID: NCT05415436

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2023-07-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A- propofol given at FDA approved administration speed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B- propofol given over 120 seconds

Group Type: EXPERIMENTAL

Propofol slow administration

Intervention Type: OTHER

Propofol will be slowly administered over 120 seconds by anesthesia provider

Interventions

Propofol slow administration

Propofol will be slowly administered over 120 seconds by anesthesia provider

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toledo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Pappada, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo

Locations

The University of Toledo Medical Center

Toledo, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Propofol study

Identifier Type: -

Identifier Source: org_study_id