Trial Outcomes & Findings for Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion (NCT NCT04187196)
NCT ID: NCT04187196
Last Updated: 2023-11-13
Results Overview
The time from initiation of sedation to full recovery Ramsay Sedation Scale (RSS) of 2 (RSS 2 means awake; cooperative, oriented, and tranquil.)-- as evidenced by the ability to answer the questions "What is your name and what is your age?" The timer will start at the initiation of induction. Recorded in minutes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
73 participants
Primary outcome timeframe
Day 1
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Sedation With Propofol Group
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
38
|
|
Overall Study
COMPLETED
|
33
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sedation With Propofol Group
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Overall Study
Screen Failure
|
2
|
0
|
Baseline Characteristics
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Baseline characteristics by cohort
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
38 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.7 kg/m^2
n=5 Participants
|
30.8 kg/m^2
n=7 Participants
|
30.7 kg/m^2
n=5 Participants
|
|
CHA2 DS2-VASc Congestive heart failure, Hypertension, Diabetes mellitus, prior Stroke
|
3 score on a scale
n=5 Participants
|
3 score on a scale
n=7 Participants
|
3 score on a scale
n=5 Participants
|
|
HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history
|
2 score on a scale
n=5 Participants
|
2 score on a scale
n=7 Participants
|
2 score on a scale
n=5 Participants
|
|
Left Atrium (LA) Diameter
|
4.3 cm
n=5 Participants
|
4.3 cm
n=7 Participants
|
4.3 cm
n=5 Participants
|
|
Left Ventricle ejection fraction (LVEF)
|
60 percentage of blood
n=5 Participants
|
60 percentage of blood
n=7 Participants
|
60 percentage of blood
n=5 Participants
|
|
Number with History of Hypertension
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
History of heart failure with reduced ejection fraction (HFrEF)
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
History of Transient Ischemic attack (TIA) or stroke
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number with History of Diabetes
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Number with History of Chronic Obstructive Pulmonary Disease (COPD)
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Number with Thyroid Disorder
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Number Currently Smoking
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number Drinking at Least 1 Time per Week
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Number of Drinkers having >2 drinks per occasion
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) classification III or IV
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Heart Rate
|
96 beats per minute (bpm)
n=5 Participants
|
93 beats per minute (bpm)
n=7 Participants
|
94 beats per minute (bpm)
n=5 Participants
|
|
Systolic Blood Pressure
|
132 mmHg
n=5 Participants
|
140 mmHg
n=7 Participants
|
138 mmHg
n=5 Participants
|
|
Diastolic Blood Pressure
|
78 mmHg
n=5 Participants
|
79.5 mmHg
n=7 Participants
|
79 mmHg
n=5 Participants
|
|
Median arterial pressure
|
104 mmHg
n=5 Participants
|
104.5 mmHg
n=7 Participants
|
104 mmHg
n=5 Participants
|
|
Respiratory Rate
|
16 respirations per minute (rpm)
n=5 Participants
|
16.5 respirations per minute (rpm)
n=7 Participants
|
16 respirations per minute (rpm)
n=5 Participants
|
|
Oxygen saturation %
|
100 percentage of oxygen saturation
n=5 Participants
|
100 percentage of oxygen saturation
n=7 Participants
|
100 percentage of oxygen saturation
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1The time from initiation of sedation to full recovery Ramsay Sedation Scale (RSS) of 2 (RSS 2 means awake; cooperative, oriented, and tranquil.)-- as evidenced by the ability to answer the questions "What is your name and what is your age?" The timer will start at the initiation of induction. Recorded in minutes.
Outcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Time From Initiation of Sedation to Full Recovery
|
7.6 minutes
Interval 6.5 to 9.8
|
5.5 minutes
Interval 4.0 to 6.9
|
SECONDARY outcome
Timeframe: Day 1Recorded in minutes.
Outcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Time From End of Injection to Loss of Conscious
|
1.0 minutes
Interval 0.8 to 1.3
|
1.0 minutes
Interval 0.8 to 1.3
|
SECONDARY outcome
Timeframe: Day 1Recorded in seconds.
Outcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Time to First Electrical Direct-current Shock
|
1.28 seconds
Interval 0.8 to 3.3
|
1.2 seconds
Interval 1.0 to 1.7
|
SECONDARY outcome
Timeframe: Day 1Recorded in seconds.
Outcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Time to Eyes Opening
|
7.0 seconds
Interval 5.7 to 9.6
|
4.2 seconds
Interval 3.3 to 6.4
|
SECONDARY outcome
Timeframe: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversionOutcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Systolic Blood Pressure
at induction
|
132 mmHg
Interval 125.5 to 146.0
|
140 mmHg
Interval 132.0 to 151.3
|
|
Systolic Blood Pressure
prior to first shock
|
138 mmHg
Interval 125.0 to 148.0
|
144 mmHg
Interval 130.0 to 153.0
|
|
Systolic Blood Pressure
1 minute after first cardioversion
|
124 mmHg
Interval 107.0 to 139.5
|
132 mmHg
Interval 121.8 to 155.3
|
|
Systolic Blood Pressure
3 minutes after first cardioversion
|
122 mmHg
Interval 106.5 to 131.5
|
140.5 mmHg
Interval 124.0 to 157.5
|
|
Systolic Blood Pressure
5 minutes after first cardioversion
|
114 mmHg
Interval 106.0 to 126.0
|
142.5 mmHg
Interval 124.8 to 158.3
|
|
Systolic Blood Pressure
7 minutes after first cardioversion
|
111 mmHg
Interval 101.0 to 122.0
|
139.5 mmHg
Interval 123.3 to 151.0
|
|
Systolic Blood Pressure
9 minutes after first cardioversion
|
111 mmHg
Interval 96.0 to 129.0
|
131 mmHg
Interval 120.0 to 143.3
|
|
Systolic Blood Pressure
10 minutes after first cardioversion
|
113 mmHg
Interval 94.5 to 123.0
|
136 mmHg
Interval 123.8 to 141.3
|
|
Systolic Blood Pressure
15 minutes after first cardioversion
|
113 mmHg
Interval 99.3 to 122.8
|
131 mmHg
Interval 115.5 to 141.5
|
|
Systolic Blood Pressure
20 minutes after first cardioversion
|
116 mmHg
Interval 101.3 to 127.8
|
127 mmHg
Interval 118.0 to 137.0
|
SECONDARY outcome
Timeframe: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversionOutcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Diastolic Blood Pressure
at induction
|
78 mmHg
Interval 67.5 to 98.5
|
79.5 mmHg
Interval 71.0 to 93.0
|
|
Diastolic Blood Pressure
prior to first shock
|
82 mmHg
Interval 69.0 to 96.0
|
81.5 mmHg
Interval 72.0 to 91.5
|
|
Diastolic Blood Pressure
1 minute after first cardioversion
|
70 mmHg
Interval 58.5 to 83.5
|
76 mmHg
Interval 67.8 to 89.3
|
|
Diastolic Blood Pressure
3 minutes after first cardioversion
|
65 mmHg
Interval 59.5 to 75.5
|
74 mmHg
Interval 66.8 to 82.0
|
|
Diastolic Blood Pressure
5 minutes after first cardioversion
|
65 mmHg
Interval 57.0 to 75.5
|
73 mmHg
Interval 69.3 to 79.0
|
|
Diastolic Blood Pressure
7 minutes after first cardioversion
|
63 mmHg
Interval 56.5 to 71.0
|
72 mmHg
Interval 66.5 to 78.0
|
|
Diastolic Blood Pressure
9 minutes after first cardioversion
|
60 mmHg
Interval 56.0 to 72.5
|
68 mmHg
Interval 63.0 to 74.3
|
|
Diastolic Blood Pressure
10 minutes after first cardioversion
|
67 mmHg
Interval 57.0 to 73.0
|
68 mmHg
Interval 63.0 to 74.0
|
|
Diastolic Blood Pressure
15 minutes after first cardioversion
|
65 mmHg
Interval 56.5 to 76.8
|
69 mmHg
Interval 62.5 to 74.5
|
|
Diastolic Blood Pressure
20 minutes after first cardioversion
|
66 mmHg
Interval 56.5 to 73.0
|
66 mmHg
Interval 61.0 to 76.5
|
|
Diastolic Blood Pressure
30 minutes after first cardioversion
|
67 mmHg
Interval 59.3 to 75.8
|
67 mmHg
Interval 61.0 to 73.0
|
SECONDARY outcome
Timeframe: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversionOutcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Mean Arterial Blood Pressure
at induction
|
104 mmHg
Interval 91.0 to 113.0
|
104.5 mmHg
Interval 96.5 to 118.3
|
|
Mean Arterial Blood Pressure
prior to first shock
|
102 mmHg
Interval 91.5 to 117.5
|
104.5 mmHg
Interval 92.8 to 115.0
|
|
Mean Arterial Blood Pressure
1 minute after first cardioversion
|
91 mmHg
Interval 74.0 to 104.0
|
101.5 mmHg
Interval 90.5 to 110.0
|
|
Mean Arterial Blood Pressure
3 minutes after first cardioversion
|
86 mmHg
Interval 80.5 to 96.5
|
104 mmHg
Interval 89.8 to 109.8
|
|
Mean Arterial Blood Pressure
5 minutes after first cardioversion
|
84 mmHg
Interval 78.0 to 96.0
|
101 mmHg
Interval 91.0 to 112.3
|
|
Mean Arterial Blood Pressure
7 minutes after first cardioversion
|
81 mmHg
Interval 72.5 to 91.5
|
99.5 mmHg
Interval 88.0 to 106.3
|
|
Mean Arterial Blood Pressure
9 minutes after first cardioversion
|
81 mmHg
Interval 72.0 to 93.0
|
95 mmHg
Interval 85.8 to 102.0
|
|
Mean Arterial Blood Pressure
10 minutes after first cardioversion
|
84 mmHg
Interval 72.5 to 92.5
|
94 mmHg
Interval 88.3 to 100.0
|
|
Mean Arterial Blood Pressure
15 minutes after first cardioversion
|
85 mmHg
Interval 76.0 to 92.8
|
92 mmHg
Interval 84.5 to 99.0
|
|
Mean Arterial Blood Pressure
20 minutes after first cardioversion
|
86 mmHg
Interval 75.3 to 91.5
|
92 mmHg
Interval 85.0 to 98.0
|
|
Mean Arterial Blood Pressure
30 minutes after first cardioversion
|
87 mmHg
Interval 78.8 to 106.1
|
93 mmHg
Interval 85.5 to 99.5
|
SECONDARY outcome
Timeframe: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversionOutcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Respiratory Rate
at induction
|
16 number of breaths per minute
Interval 12.5 to 20.0
|
16.5 number of breaths per minute
Interval 14.0 to 21.3
|
|
Respiratory Rate
prior to first shock
|
18 number of breaths per minute
Interval 13.5 to 21.5
|
16.5 number of breaths per minute
Interval 14.8 to 23.0
|
|
Respiratory Rate
1 minute after first cardioversion
|
17 number of breaths per minute
Interval 11.0 to 22.0
|
17 number of breaths per minute
Interval 12.8 to 22.0
|
|
Respiratory Rate
3 minutes after first cardioversion
|
19 number of breaths per minute
Interval 15.0 to 22.5
|
19.5 number of breaths per minute
Interval 17.0 to 22.3
|
|
Respiratory Rate
5 minutes after first cardioversion
|
19 number of breaths per minute
Interval 16.0 to 22.5
|
18.5 number of breaths per minute
Interval 16.0 to 22.3
|
|
Respiratory Rate
7 minutes after first cardioversion
|
19 number of breaths per minute
Interval 15.5 to 22.0
|
19.5 number of breaths per minute
Interval 15.0 to 22.0
|
|
Respiratory Rate
9 minutes after first cardioversion
|
18 number of breaths per minute
Interval 15.5 to 22.5
|
17 number of breaths per minute
Interval 15.0 to 21.5
|
|
Respiratory Rate
10 minutes after first cardioversion
|
18 number of breaths per minute
Interval 15.5 to 21.5
|
18 number of breaths per minute
Interval 13.5 to 22.3
|
|
Respiratory Rate
15 minutes after first cardioversion
|
18 number of breaths per minute
Interval 13.0 to 22.0
|
17 number of breaths per minute
Interval 15.0 to 20.5
|
|
Respiratory Rate
20 minutes after first cardioversion
|
17 number of breaths per minute
Interval 15.0 to 20.0
|
18 number of breaths per minute
Interval 15.0 to 21.0
|
|
Respiratory Rate
30 minutes after first cardioversion
|
18 number of breaths per minute
Interval 16.0 to 20.0
|
18 number of breaths per minute
Interval 15.0 to 20.5
|
SECONDARY outcome
Timeframe: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversionOutcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Saturation of Peripheral Oxygen (SpO2)
at induction
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
prior to first shock
|
100 percentage of oxygen saturation
Interval 99.5 to 100.0
|
100 percentage of oxygen saturation
Interval 100.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
1 minute after first cardioversion
|
98 percentage of oxygen saturation
Interval 97.0 to 100.0
|
99.5 percentage of oxygen saturation
Interval 97.8 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
3 minutes after first cardioversion
|
99 percentage of oxygen saturation
Interval 97.5 to 100.0
|
100 percentage of oxygen saturation
Interval 98.8 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
5 minutes after first cardioversion
|
99 percentage of oxygen saturation
Interval 99.0 to 100.0
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
7 minutes after first cardioversion
|
99 percentage of oxygen saturation
Interval 99.0 to 100.0
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
9 minutes after first cardioversion
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
100 percentage of oxygen saturation
Interval 99.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
10 minutes after first cardioversion
|
100 percentage of oxygen saturation
Interval 98.0 to 100.0
|
100 percentage of oxygen saturation
Interval 98.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
15 minutes after first cardioversion
|
100 percentage of oxygen saturation
Interval 98.0 to 100.0
|
100 percentage of oxygen saturation
Interval 98.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
20 minutes after first cardioversion
|
99 percentage of oxygen saturation
Interval 98.0 to 100.0
|
99 percentage of oxygen saturation
Interval 98.0 to 100.0
|
|
Saturation of Peripheral Oxygen (SpO2)
30 minutes after first cardioversion
|
98 percentage of oxygen saturation
Interval 97.0 to 100.0
|
98 percentage of oxygen saturation
Interval 96.5 to 99.5
|
SECONDARY outcome
Timeframe: Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversionOutcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Heart Rate
3 minutes after first cardioversion
|
66 beats per minute
Interval 60.0 to 76.5
|
73.5 beats per minute
Interval 62.5 to 84.5
|
|
Heart Rate
5 minutes after first cardioversion
|
69 beats per minute
Interval 61.0 to 74.0
|
69 beats per minute
Interval 60.8 to 81.3
|
|
Heart Rate
at induction
|
96 beats per minute
Interval 79.0 to 115.0
|
93 beats per minute
Interval 77.0 to 128.0
|
|
Heart Rate
prior to first shock
|
100 beats per minute
Interval 84.5 to 118.5
|
92 beats per minute
Interval 75.8 to 122.0
|
|
Heart Rate
1 minute after first cardioversion
|
69 beats per minute
Interval 62.5 to 78.0
|
73.5 beats per minute
Interval 66.0 to 84.3
|
|
Heart Rate
7 minutes after first cardioversion
|
66 beats per minute
Interval 59.5 to 71.5
|
69 beats per minute
Interval 59.8 to 78.3
|
|
Heart Rate
9 minutes after first cardioversion
|
65 beats per minute
Interval 59.0 to 73.0
|
67.5 beats per minute
Interval 60.8 to 78.3
|
|
Heart Rate
10 minutes after first cardioversion
|
64 beats per minute
Interval 58.0 to 74.0
|
68 beats per minute
Interval 59.5 to 79.3
|
|
Heart Rate
15 minutes after first cardioversion
|
64.5 beats per minute
Interval 59.0 to 72.5
|
68 beats per minute
Interval 59.5 to 77.5
|
|
Heart Rate
20 minutes after first cardioversion
|
62.5 beats per minute
Interval 58.3 to 72.0
|
68 beats per minute
Interval 59.5 to 74.5
|
|
Heart Rate
30 minutes after first cardioversion
|
65.5 beats per minute
Interval 61.0 to 72.3
|
69 beats per minute
Interval 60.0 to 75.5
|
SECONDARY outcome
Timeframe: Day 1These are 100 mm lines that are anchored with "no pain" on one end and "worst imaginable pain" on the other end. Total range 0-100, higher numbers correspond to worse pain.
Outcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Recall of Pain at Injection Site - Visual Analog Scale
|
8 score on a scale
Interval 1.0 to 46.0
|
2 score on a scale
Interval 0.0 to 11.5
|
SECONDARY outcome
Timeframe: Day 1These are 100 mm lines that are anchored with "no distress" on one end and "worst imaginable distress" on the other end. Total range 0-100, higher numbers correspond to worse distress.
Outcome measures
| Measure |
Sedation With Propofol Group
n=33 Participants
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 Participants
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Recall of Anything Unpleasant About the Procedure - Visual Analog Scale
|
3 score on a scale
Interval 0.0 to 19.0
|
1 score on a scale
Interval 0.0 to 12.5
|
Adverse Events
Sedation With Propofol Group
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Sedation With Methohexital Group
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sedation With Propofol Group
n=33 participants at risk
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 participants at risk
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Severe Oxygen Desaturation (<75% or <90% at 60s)
|
3.0%
1/33 • Number of events 1 • Baseline through the end of study (approximately 1 day)
|
0.00%
0/38 • Baseline through the end of study (approximately 1 day)
|
Other adverse events
| Measure |
Sedation With Propofol Group
n=33 participants at risk
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
Propofol: Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
|
Sedation With Methohexital Group
n=38 participants at risk
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
Methohexital: Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
33.3%
11/33 • Number of events 12 • Baseline through the end of study (approximately 1 day)
|
31.6%
12/38 • Number of events 12 • Baseline through the end of study (approximately 1 day)
|
|
Cardiac disorders
Hypotension
|
42.4%
14/33 • Number of events 14 • Baseline through the end of study (approximately 1 day)
|
10.5%
4/38 • Number of events 4 • Baseline through the end of study (approximately 1 day)
|
|
Social circumstances
Hypoxemia
|
15.2%
5/33 • Number of events 5 • Baseline through the end of study (approximately 1 day)
|
0.00%
0/38 • Baseline through the end of study (approximately 1 day)
|
|
Musculoskeletal and connective tissue disorders
Jaw thrust or chin lift
|
42.4%
14/33 • Number of events 14 • Baseline through the end of study (approximately 1 day)
|
15.8%
6/38 • Number of events 6 • Baseline through the end of study (approximately 1 day)
|
|
Respiratory, thoracic and mediastinal disorders
Apnea >20 seconds
|
30.3%
10/33 • Number of events 10 • Baseline through the end of study (approximately 1 day)
|
15.8%
6/38 • Number of events 6 • Baseline through the end of study (approximately 1 day)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place