Trial Outcomes & Findings for Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement (NCT NCT02786264)
NCT ID: NCT02786264
Last Updated: 2023-04-24
Results Overview
Procedure length will be collected from retrospective analysis of charts.
Recruitment status
COMPLETED
Target enrollment
186 participants
Primary outcome timeframe
During surgery
Results posted on
2023-04-24
Participant Flow
This study was a retrospective chart review and did not include prospective enrollment. As noted in the pre-assignment details, the number of enrolled participants was determined by chart review.
As specified above, this study was a retrospective chart review and thus enrollment was determined by existence of charts rather than by prospective enrollment. While patients were screened for other modes of sedation, data were only collected on the two groups included presently.
Participant milestones
| Measure |
Propofol-dominant Sedation
Patients receiving propofol infusion for TAVR as the primary drug for sedation.
Propofol: A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start.
|
Propofol With Dexmedetomidine Group
Patients who qualified for Both the Propofol Dominant and the Dexmedetomidine Dominant group were categorized into this fourth group.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
34
|
|
Overall Study
COMPLETED
|
39
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Propofol and Dexmedetomidine
n=34 Participants
Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam
|
Propofol Only
n=39 Participants
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
84 years
n=99 Participants
|
87 years
n=107 Participants
|
87 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
31 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Height
|
1.6 meters
n=99 Participants
|
1.6 meters
n=107 Participants
|
1.6 meters
n=206 Participants
|
|
Weight
|
71.5 kg
n=99 Participants
|
76.6 kg
n=107 Participants
|
73.7 kg
n=206 Participants
|
|
Body Mass Index (BMI)
|
25.6 kg/m^2
n=99 Participants
|
29.2 kg/m^2
n=107 Participants
|
26.7 kg/m^2
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Score
3
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Score
4
|
29 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification
2
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification
3
|
24 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification
4
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
63 %
n=99 Participants
|
62 %
n=107 Participants
|
62 %
n=206 Participants
|
|
Alcoholism
No
|
34 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Alcoholism
Yes
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Anxiety disorder
No
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Anxiety disorder
Yes
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Atrial fibrillation
No
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Atrial fibrillation
Yes
|
12 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Cerebrovascular disease
No
|
29 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Cerebrovascular disease
Yes
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Congestive Heart Failure (CHF)
No
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Congestive Heart Failure (CHF)
Yes
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Coronary Artery Disease (CAD)
No
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Coronary Artery Disease (CAD)
Yes
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Diabetes
No
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Diabetes
Yes
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Hypertension
No
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Hypertension
Yes
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Depression
No
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Depression
Yes
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Obstructive sleep apnea
No
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Obstructive sleep apnea
Yes
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Peripheral vascular disease
No
|
27 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Peripheral vascular disease
Yes
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Psychosis
No
|
34 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Psychosis
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Renal disease
No
|
22 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Renal disease
Yes
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Substance abuse
No
|
34 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Substance abuse
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During surgeryPopulation: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
Procedure length will be collected from retrospective analysis of charts.
Outcome measures
| Measure |
Propofol and Dexmedetomidine
n=34 Participants
Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam
|
Propofol Only
n=39 Participants
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
|
|---|---|---|
|
Procedure Length
|
114.5 minutes
Interval 102.0 to 137.0
|
100 minutes
Interval 87.0 to 123.0
|
SECONDARY outcome
Timeframe: From the conclusion of surgery until patient leaves the ICU, up to 2 weeksPopulation: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
ICU length of stay will be collected from retrospective analysis of charts.
Outcome measures
| Measure |
Propofol and Dexmedetomidine
n=34 Participants
Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam
|
Propofol Only
n=39 Participants
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
|
|---|---|---|
|
ICU Length of Stay
|
1 days
Interval 1.0 to 1.0
|
1 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: During surgeryPopulation: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.
Outcome measures
| Measure |
Propofol and Dexmedetomidine
n=34 Participants
Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam
|
Propofol Only
n=39 Participants
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
|
|---|---|---|
|
Rate of Conversion to General Anesthesia
Yes
|
3 Participants
|
1 Participants
|
|
Rate of Conversion to General Anesthesia
No
|
31 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: From the conclusion of surgery until patient is discharged, up to 2 weeksPopulation: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
Hospital length of stay will be collected via retrospective analysis of charts.
Outcome measures
| Measure |
Propofol and Dexmedetomidine
n=34 Participants
Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam
|
Propofol Only
n=39 Participants
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
|
|---|---|---|
|
Hospital Length of Stay
|
2 days
Interval 2.0 to 3.0
|
2 days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: From the conclusion of surgery until patient is discharged, up to 2 weeksPopulation: NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort.
Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician.
Outcome measures
| Measure |
Propofol and Dexmedetomidine
n=34 Participants
Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam
|
Propofol Only
n=39 Participants
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
|
|---|---|---|
|
Delirium Incidence
No
|
34 Participants
|
38 Participants
|
|
Delirium Incidence
Yes
|
0 Participants
|
1 Participants
|
Adverse Events
Propofol and Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place