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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A- propofol given at FDA approved administration speed | No Intervention | ||
| Group B- propofol given over 120 seconds | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol slow administration | Other | Propofol will be slowly administered over 120 seconds by anesthesia provider |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediate post-op to 30 days post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Pappada, PhD | University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A- Propofol Given at FDA Approved Administration Speed | propofol given at FDA approved administration speed |
| FG001 | Group B- Propofol Given Over 120 Seconds | Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A- Propofol Given at FDA Approved Administration Speed | propofol given at FDA approved administration speed |
| BG001 | Group B- Propofol Given Over 120 Seconds | Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | induction to 1 hour post induction |
|
Data was collected from date of enrollment in the study, which was the patient's procedure date, to 30 days post-operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A- Propofol Given at FDA Approved Administration Speed | propofol given at FDA approved administration speed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| participant died 5 days post study procedure due to multi system organ failure | Vascular disorders | Systematic Assessment | investigator determined that cause of death was unrelated to study procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristi Baker BSN, RN | The University of Toledo Medical Center | 4193836223 | kristi.baker@utoledo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2024 | Mar 3, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2023 | Jun 28, 2024 | ICF_001.pdf |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | immediate post-op to 30 days post operatively |
|
|
|
| 1 |
| 53 |
| 1 |
| 53 |
| 0 |
| 53 |
| EG001 | Group B- Propofol Given Over 120 Seconds | Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider | 0 | 46 | 0 | 46 | 0 | 46 |
|
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