Hypotension on Induction
Conditions
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.
Interventions
OTHERPropofol slow administration
Propofol will be slowly administered over 120 seconds by anesthesia provider
Sponsors
University of Toledo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | We will collect the patient's blood pressure post-operatively and length of hospital stay and compare. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A- Propofol Given at FDA Approved Administration Speed propofol given at FDA approved administration speed | 54 |
| Group B- Propofol Given Over 120 Seconds Propofol slow administration: Propofol will be slowly administered over 120 seconds by anesthesia provider | 46 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Surgeon cancelled procedure | 1 | 0 |
Baseline characteristics
| Characteristic | Group B- Propofol Given Over 120 Seconds | Total | Group A- Propofol Given at FDA Approved Administration Speed |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 32 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 68 Participants | 36 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 46 participants | 100 participants | 54 participants |
| Sex: Female, Male Female | 25 Participants | 55 Participants | 30 Participants |
| Sex: Female, Male Male | 21 Participants | 45 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 53 | 0 / 46 |
| other Total, other adverse events | 0 / 53 | 0 / 46 |
| serious Total, serious adverse events | 1 / 53 | 0 / 46 |
Outcome results
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.
Time frame: induction to 1 hour post induction
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A- Propofol Given at FDA Approved Administration Speed | 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 |
| Group A- Propofol Given at FDA Approved Administration Speed | 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 |
| Group B- Propofol Given Over 120 Seconds | 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 | 2 Participants |
| Group B- Propofol Given Over 120 Seconds | 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 | 44 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.
Time frame: immediate post-op to 30 days post operatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A- Propofol Given at FDA Approved Administration Speed | 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 |
| Group A- Propofol Given at FDA Approved Administration Speed | 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 |
| Group B- Propofol Given Over 120 Seconds | 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 | 0 Participants |
| Group B- Propofol Given Over 120 Seconds | 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 | 0 Participants |