Atrial Fibrillation, Atrial Flutter
Conditions
Keywords
Cardioversion, Propofol, Deep sedation, Intravenous anesthetics
Brief summary
A randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct current cardioversion (DCCV) when using methohexital when compared to the more often used propofol.
Detailed description
The investigators theorize that the use of methohexital during cardioversion will result in a shorter time to effective sedation and time to full recovery when compared to the use of propofol. This will change how sedation is approached for elective cardioversions. Primary Hypothesis: 1. The mean time to recovery from sedation during a cardioversion using methohexital for sedation will be significantly shorter than the recovery time using propofol for sedation, as evidenced by a short time from initiation of induction to a score of 2 on the Ramsay Sedation Scale. 2. The mean time to a Ramsay score of 5-6 will be significantly shorter using methohexital than the time to the same sedation level using propofol Secondary Hypothesis: 1\. There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.
Interventions
DRUGPropofol
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
DRUGMethohexital
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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who present to Wake Forest Baptist Medical Center for a direct current cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as atrial flutter.
Exclusion criteria
* Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV * Hemodynamically compromised patients (as defined by hypotension \<90/50 mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Initiation of Sedation to Full Recovery | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Electrical Direct-current Shock | Day 1 | Recorded in seconds. |
| Time to Eyes Opening | Day 1 | Recorded in seconds. |
| Systolic Blood Pressure | 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 cardioversion | — |
| Diastolic Blood Pressure | 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 cardioversion | — |
| Mean Arterial Blood Pressure | 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 cardioversion | — |
| Time From End of Injection to Loss of Conscious | Day 1 | Recorded in minutes. |
| Saturation of Peripheral Oxygen (SpO2) | 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 cardioversion | — |
| Heart Rate | 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 cardioversion | — |
| Recall of Pain at Injection Site - Visual Analog Scale | Day 1 | These 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. |
| Recall of Anything Unpleasant About the Procedure - Visual Analog Scale | Day 1 | These 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. |
| Respiratory Rate | 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 cardioversion | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| 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 | 38 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen Failure | 2 | 0 |
Baseline characteristics
| Characteristic | Sedation With Propofol Group | Sedation With Methohexital Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 31 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 17 Participants |
| American Society of Anesthesiologists (ASA) classification III or IV | 26 Participants | 32 Participants | 58 Participants |
| Body Mass Index (BMI) | 30.7 kg/m^2 | 30.8 kg/m^2 | 30.7 kg/m^2 |
| CHA2 DS2-VASc Congestive heart failure, Hypertension, Diabetes mellitus, prior Stroke | 3 score on a scale | 3 score on a scale | 3 score on a scale |
| Diastolic Blood Pressure | 78 mmHg | 79.5 mmHg | 79 mmHg |
| HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history | 2 score on a scale | 2 score on a scale | 2 score on a scale |
| Heart Rate | 96 beats per minute (bpm) | 93 beats per minute (bpm) | 94 beats per minute (bpm) |
| History of heart failure with reduced ejection fraction (HFrEF) | 3 Participants | 8 Participants | 11 Participants |
| History of Transient Ischemic attack (TIA) or stroke | 4 Participants | 3 Participants | 7 Participants |
| Left Atrium (LA) Diameter | 4.3 cm | 4.3 cm | 4.3 cm |
| Left Ventricle ejection fraction (LVEF) | 60 percentage of blood | 60 percentage of blood | 60 percentage of blood |
| Median arterial pressure | 104 mmHg | 104.5 mmHg | 104 mmHg |
| Number Currently Smoking | 6 Participants | 3 Participants | 9 Participants |
| Number Drinking at Least 1 Time per Week | 9 Participants | 14 Participants | 23 Participants |
| Number of Drinkers having >2 drinks per occasion | 4 Participants | 4 Participants | 8 Participants |
| Number with History of Chronic Obstructive Pulmonary Disease (COPD) | 6 Participants | 6 Participants | 12 Participants |
| Number with History of Diabetes | 11 Participants | 11 Participants | 22 Participants |
| Number with History of Hypertension | 29 Participants | 34 Participants | 63 Participants |
| Number with Thyroid Disorder | 11 Participants | 10 Participants | 21 Participants |
| Oxygen saturation % | 100 percentage of oxygen saturation | 100 percentage of oxygen saturation | 100 percentage of oxygen saturation |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 33 Participants | 63 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 33 participants | 38 participants | 71 participants |
| Respiratory Rate | 16 respirations per minute (rpm) | 16.5 respirations per minute (rpm) | 16 respirations per minute (rpm) |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 42 Participants |
| Systolic Blood Pressure | 132 mmHg | 140 mmHg | 138 mmHg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 38 |
| other Total, other adverse events | 14 / 33 | 24 / 38 |
| serious Total, serious adverse events | 1 / 33 | 0 / 38 |
Outcome results
Primary
Time From Initiation of Sedation to Full Recovery
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.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sedation With Propofol Group | Time From Initiation of Sedation to Full Recovery | 7.6 minutes |
| Sedation With Methohexital Group | Time From Initiation of Sedation to Full Recovery | 5.5 minutes |
Secondary
Diastolic Blood Pressure
Time frame: 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 cardioversion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sedation With Propofol Group | Diastolic Blood Pressure | at induction | 78 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | prior to first shock | 82 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 1 minute after first cardioversion | 70 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 3 minutes after first cardioversion | 65 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 5 minutes after first cardioversion | 65 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 7 minutes after first cardioversion | 63 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 9 minutes after first cardioversion | 60 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 10 minutes after first cardioversion | 67 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 15 minutes after first cardioversion | 65 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 20 minutes after first cardioversion | 66 mmHg |
| Sedation With Propofol Group | Diastolic Blood Pressure | 30 minutes after first cardioversion | 67 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 30 minutes after first cardioversion | 67 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | at induction | 79.5 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 7 minutes after first cardioversion | 72 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | prior to first shock | 81.5 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 20 minutes after first cardioversion | 66 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 1 minute after first cardioversion | 76 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 9 minutes after first cardioversion | 68 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 3 minutes after first cardioversion | 74 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 15 minutes after first cardioversion | 69 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 5 minutes after first cardioversion | 73 mmHg |
| Sedation With Methohexital Group | Diastolic Blood Pressure | 10 minutes after first cardioversion | 68 mmHg |
Secondary
Heart Rate
Time frame: 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 cardioversion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sedation With Propofol Group | Heart Rate | 3 minutes after first cardioversion | 66 beats per minute |
| Sedation With Propofol Group | Heart Rate | 9 minutes after first cardioversion | 65 beats per minute |
| Sedation With Propofol Group | Heart Rate | 1 minute after first cardioversion | 69 beats per minute |
| Sedation With Propofol Group | Heart Rate | 10 minutes after first cardioversion | 64 beats per minute |
| Sedation With Propofol Group | Heart Rate | 5 minutes after first cardioversion | 69 beats per minute |
| Sedation With Propofol Group | Heart Rate | 15 minutes after first cardioversion | 64.5 beats per minute |
| Sedation With Propofol Group | Heart Rate | prior to first shock | 100 beats per minute |
| Sedation With Propofol Group | Heart Rate | 20 minutes after first cardioversion | 62.5 beats per minute |
| Sedation With Propofol Group | Heart Rate | 7 minutes after first cardioversion | 66 beats per minute |
| Sedation With Propofol Group | Heart Rate | 30 minutes after first cardioversion | 65.5 beats per minute |
| Sedation With Propofol Group | Heart Rate | at induction | 96 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 30 minutes after first cardioversion | 69 beats per minute |
| Sedation With Methohexital Group | Heart Rate | at induction | 93 beats per minute |
| Sedation With Methohexital Group | Heart Rate | prior to first shock | 92 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 1 minute after first cardioversion | 73.5 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 3 minutes after first cardioversion | 73.5 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 5 minutes after first cardioversion | 69 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 7 minutes after first cardioversion | 69 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 9 minutes after first cardioversion | 67.5 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 10 minutes after first cardioversion | 68 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 15 minutes after first cardioversion | 68 beats per minute |
| Sedation With Methohexital Group | Heart Rate | 20 minutes after first cardioversion | 68 beats per minute |
Secondary
Mean Arterial Blood Pressure
Time frame: 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 cardioversion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 3 minutes after first cardioversion | 86 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 9 minutes after first cardioversion | 81 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 1 minute after first cardioversion | 91 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 10 minutes after first cardioversion | 84 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 5 minutes after first cardioversion | 84 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 15 minutes after first cardioversion | 85 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | prior to first shock | 102 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 20 minutes after first cardioversion | 86 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 7 minutes after first cardioversion | 81 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | 30 minutes after first cardioversion | 87 mmHg |
| Sedation With Propofol Group | Mean Arterial Blood Pressure | at induction | 104 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 30 minutes after first cardioversion | 93 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | at induction | 104.5 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | prior to first shock | 104.5 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 1 minute after first cardioversion | 101.5 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 3 minutes after first cardioversion | 104 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 5 minutes after first cardioversion | 101 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 7 minutes after first cardioversion | 99.5 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 9 minutes after first cardioversion | 95 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 10 minutes after first cardioversion | 94 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 15 minutes after first cardioversion | 92 mmHg |
| Sedation With Methohexital Group | Mean Arterial Blood Pressure | 20 minutes after first cardioversion | 92 mmHg |
Secondary
Recall of Anything Unpleasant About the Procedure - Visual Analog Scale
These 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.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sedation With Propofol Group | Recall of Anything Unpleasant About the Procedure - Visual Analog Scale | 3 score on a scale |
| Sedation With Methohexital Group | Recall of Anything Unpleasant About the Procedure - Visual Analog Scale | 1 score on a scale |
Secondary
Recall of Pain at Injection Site - Visual Analog Scale
These 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.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sedation With Propofol Group | Recall of Pain at Injection Site - Visual Analog Scale | 8 score on a scale |
| Sedation With Methohexital Group | Recall of Pain at Injection Site - Visual Analog Scale | 2 score on a scale |
Secondary
Respiratory Rate
Time frame: 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 cardioversion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sedation With Propofol Group | Respiratory Rate | at induction | 16 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 3 minutes after first cardioversion | 19 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 30 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 5 minutes after first cardioversion | 19 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | prior to first shock | 18 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 7 minutes after first cardioversion | 19 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 20 minutes after first cardioversion | 17 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 9 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 1 minute after first cardioversion | 17 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 10 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Propofol Group | Respiratory Rate | 15 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 10 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 15 minutes after first cardioversion | 17 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 20 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 30 minutes after first cardioversion | 18 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | at induction | 16.5 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | prior to first shock | 16.5 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 1 minute after first cardioversion | 17 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 3 minutes after first cardioversion | 19.5 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 5 minutes after first cardioversion | 18.5 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 7 minutes after first cardioversion | 19.5 number of breaths per minute |
| Sedation With Methohexital Group | Respiratory Rate | 9 minutes after first cardioversion | 17 number of breaths per minute |
Secondary
Saturation of Peripheral Oxygen (SpO2)
Time frame: 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 cardioversion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 1 minute after first cardioversion | 98 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 7 minutes after first cardioversion | 99 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | prior to first shock | 100 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 9 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 3 minutes after first cardioversion | 99 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 10 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 30 minutes after first cardioversion | 98 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 15 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 5 minutes after first cardioversion | 99 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | 20 minutes after first cardioversion | 99 percentage of oxygen saturation |
| Sedation With Propofol Group | Saturation of Peripheral Oxygen (SpO2) | at induction | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 20 minutes after first cardioversion | 99 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 30 minutes after first cardioversion | 98 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | at induction | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | prior to first shock | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 1 minute after first cardioversion | 99.5 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 3 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 5 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 7 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 9 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 10 minutes after first cardioversion | 100 percentage of oxygen saturation |
| Sedation With Methohexital Group | Saturation of Peripheral Oxygen (SpO2) | 15 minutes after first cardioversion | 100 percentage of oxygen saturation |
Secondary
Systolic Blood Pressure
Time frame: 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 cardioversion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sedation With Propofol Group | Systolic Blood Pressure | at induction | 132 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | prior to first shock | 138 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 1 minute after first cardioversion | 124 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 3 minutes after first cardioversion | 122 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 5 minutes after first cardioversion | 114 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 7 minutes after first cardioversion | 111 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 9 minutes after first cardioversion | 111 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 10 minutes after first cardioversion | 113 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 15 minutes after first cardioversion | 113 mmHg |
| Sedation With Propofol Group | Systolic Blood Pressure | 20 minutes after first cardioversion | 116 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 10 minutes after first cardioversion | 136 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | at induction | 140 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 7 minutes after first cardioversion | 139.5 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | prior to first shock | 144 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 20 minutes after first cardioversion | 127 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 1 minute after first cardioversion | 132 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 9 minutes after first cardioversion | 131 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 3 minutes after first cardioversion | 140.5 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 15 minutes after first cardioversion | 131 mmHg |
| Sedation With Methohexital Group | Systolic Blood Pressure | 5 minutes after first cardioversion | 142.5 mmHg |
Secondary
Time From End of Injection to Loss of Conscious
Recorded in minutes.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sedation With Propofol Group | Time From End of Injection to Loss of Conscious | 1.0 minutes |
| Sedation With Methohexital Group | Time From End of Injection to Loss of Conscious | 1.0 minutes |
Secondary
Time to Eyes Opening
Recorded in seconds.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sedation With Propofol Group | Time to Eyes Opening | 7.0 seconds |
| Sedation With Methohexital Group | Time to Eyes Opening | 4.2 seconds |
Secondary
Time to First Electrical Direct-current Shock
Recorded in seconds.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sedation With Propofol Group | Time to First Electrical Direct-current Shock | 1.28 seconds |
| Sedation With Methohexital Group | Time to First Electrical Direct-current Shock | 1.2 seconds |