Back to resultsAnalyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure
Primary Purpose
Hypotension on Induction
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Propofol slow administration
Sponsored by
About this trial
This is an interventional other trial for Hypotension on Induction
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
Sites / Locations
- The University of Toledo Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group A- propofol given at FDA approved administration speed
Group B- propofol given over 120 seconds
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05415436
Brief Title
Analyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure
Official Title
Analyzing the Relationship Between Rate of Induction and Perioperative Hypotension Using Propofol
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A- propofol given at FDA approved administration speed
Arm Type
No Intervention
Arm Title
Group B- propofol given over 120 seconds
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Propofol slow administration
Intervention Description
Propofol will be slowly administered over 120 seconds by anesthesia provider
Primary Outcome Measure Information:
Title
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.
Description
We will collect the patient's blood pressure intra-operatively every 5 minutes starting on induction up to one hour after induction and compare.
Time Frame
induction to 1 hour post induction
Secondary Outcome Measure Information:
Title
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.
Description
We will collect the patient's blood pressure post-operatively and length of hospital stay and compare.
Time Frame
immediate post-op to 30 days post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanaya Sparkle, MD
Phone
419-383-3556
Email
tanaya.sparkle@utoledo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristi Baker, RN
Phone
419-383-6223
Email
kristi.baker@utoledo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanaya Sparkle
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanaya Sparkle, MD
Phone
419-383-3556
Email
tanaya.sparkle@utoledo.edu
First Name & Middle Initial & Last Name & Degree
Kristi Baker, RN
Phone
4193836223
Email
kristi.baker@utoledo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure
We'll reach out to this number within 24 hrs