Trial Outcomes & Findings for Analyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure (NCT NCT05415436)

NCT ID: NCT05415436

Last Updated: 2025-03-21

Results Overview

We will collect the patient's blood pressure intra-operatively every 5 minutes starting on induction up to one hour after induction and compare.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: induction to 1 hour post induction
• Results posted on: 2025-03-21

Participant Flow

Participant milestones

Measure	Group A- Propofol Given at FDA Approved Administration Speed propofol given at FDA approved administration speed	Group B- Propofol Given Over 120 Seconds Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider
Overall Study STARTED	54	46
Overall Study COMPLETED	52	46
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Group A- Propofol Given at FDA Approved Administration Speed propofol given at FDA approved administration speed	Group B- Propofol Given Over 120 Seconds Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider
Overall Study Surgeon cancelled procedure	1	0
Overall Study Death	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group A- Propofol Given at FDA Approved Administration Speed n=54 Participants propofol given at FDA approved administration speed	Group B- Propofol Given Over 120 Seconds n=46 Participants Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants	0 Participants n=46 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=54 Participants	32 Participants n=46 Participants	68 Participants n=100 Participants
Age, Categorical >=65 years	18 Participants n=54 Participants	14 Participants n=46 Participants	32 Participants n=100 Participants
Sex: Female, Male Female	30 Participants n=54 Participants	25 Participants n=46 Participants	55 Participants n=100 Participants
Sex: Female, Male Male	24 Participants n=54 Participants	21 Participants n=46 Participants	45 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	54 participants n=54 Participants	46 participants n=46 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: induction to 1 hour post induction

We will collect the patient's blood pressure intra-operatively every 5 minutes starting on induction up to one hour after induction and compare.

Outcome measures

Measure	Group A- Propofol Given at FDA Approved Administration Speed n=53 Participants propofol given at FDA approved administration speed	Group B- Propofol Given Over 120 Seconds n=46 Participants Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider
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. Number of participants with post induction hypotension	4 Participants	2 Participants
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. Number of participants without post induction hypotension	49 Participants	44 Participants

SECONDARY outcome

Timeframe: immediate post-op to 30 days post operatively

We will collect the patient's blood pressure post-operatively and length of hospital stay and compare.

Outcome measures

Measure	Group A- Propofol Given at FDA Approved Administration Speed n=53 Participants propofol given at FDA approved administration speed	Group B- Propofol Given Over 120 Seconds n=46 Participants Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider
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. Participants requiring albumin administration	4 Participants	0 Participants
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. Participants requiring vasopressin administration	4 Participants	0 Participants

Adverse Events

Group A- Propofol Given at FDA Approved Administration Speed

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Group B- Propofol Given Over 120 Seconds

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A- Propofol Given at FDA Approved Administration Speed n=53 participants at risk propofol given at FDA approved administration speed	Group B- Propofol Given Over 120 Seconds n=46 participants at risk Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider
Vascular disorders participant died 5 days post study procedure due to multi system organ failure	1.9% 1/53 • Number of events 1 • Data was collected from date of enrollment in the study, which was the patient's procedure date, to 30 days post-operatively.	0.00% 0/46 • Data was collected from date of enrollment in the study, which was the patient's procedure date, to 30 days post-operatively.

Other adverse events

Adverse event data not reported

Additional Information

Kristi Baker BSN, RN

The University of Toledo Medical Center

Phone: 4193836223

Email: kristi.baker@utoledo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place