Trial Outcomes & Findings for Self-management of Sedative Therapy by Ventilated Patients (NCT NCT02819141)

NCT ID: NCT02819141

Last Updated: 2025-10-02

Results Overview

Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 161 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2025-10-02

Participant Flow

Participant milestones

Measure	Control These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
Overall Study STARTED	81	80
Overall Study COMPLETED	75	60
Overall Study NOT COMPLETED	6	20

Reasons for withdrawal

Measure	Control These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
Overall Study Extubated or discontinued prior to day 7	6	20

Baseline Characteristics

Self-management of Sedative Therapy by Ventilated Patients

Baseline characteristics by cohort

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.	Total n=161 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 13.8 • n=5 Participants	56.2 years STANDARD_DEVIATION 16.0 • n=7 Participants	58.9 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=5 Participants	79 Participants n=7 Participants	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	74 Participants n=7 Participants	149 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	81 Participants n=5 Participants	80 Participants n=7 Participants	161 Participants n=5 Participants
Acute Physiology and Chronic Health Evaluation (APACHE) III score	80.0 units on a scale n=5 Participants	85.5 units on a scale n=7 Participants	82 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Not all enrolled patients able to respond to each assessment time point for anxiety ratings. They may have been extubated and completed the ICU study phase, withdrew from the study, or died.

Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.

Outcome measures

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 1 afternoon	40.5 score on a scale Standard Deviation 31.8	33.1 score on a scale Standard Deviation 30.9
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 1 evening	45.1 score on a scale Standard Deviation 32.4	40.9 score on a scale Standard Deviation 35.7
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 2 morning	49.8 score on a scale Standard Deviation 30.9	44.6 score on a scale Standard Deviation 34.4
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 3 morning	48 score on a scale Standard Deviation 35.0	49.8 score on a scale Standard Deviation 39.8
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 3 afternoon	43.3 score on a scale Standard Deviation 33.9	58.6 score on a scale Standard Deviation 40.1
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 3 evening	47.3 score on a scale Standard Deviation 39.2	48.1 score on a scale Standard Deviation 33.1
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 4 morning	43.4 score on a scale Standard Deviation 35.0	52.4 score on a scale Standard Deviation 30.8
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 4 afternoon	43.3 score on a scale Standard Deviation 35.5	51.4 score on a scale Standard Deviation 36.9
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 4 evening	48.2 score on a scale Standard Deviation 34.7	44.1 score on a scale Standard Deviation 39.7
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 5 afternoon	39.6 score on a scale Standard Deviation 27.4	32.0 score on a scale Standard Deviation 28.7
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 5 evening	50.7 score on a scale Standard Deviation 37.6	39.6 score on a scale Standard Deviation 25.6
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 6 morning	39.5 score on a scale Standard Deviation 31.1	46.1 score on a scale Standard Deviation 31.4
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 6 afternoon	33.1 score on a scale Standard Deviation 28.0	53.3 score on a scale Standard Deviation 26.9
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 6 evening	55.7 score on a scale Standard Deviation 33.1	38.0 score on a scale Standard Deviation 34.4
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 7 morning	47.0 score on a scale Standard Deviation 29.3	74.4 score on a scale Standard Deviation 14.9
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 1 morning	44.4 score on a scale Standard Deviation 33.2	43.4 score on a scale Standard Deviation 33.4
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 2 afternoon	41.9 score on a scale Standard Deviation 33.4	41.4 score on a scale Standard Deviation 38.5
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 2 evening	50.9 score on a scale Standard Deviation 32.7	54.9 score on a scale Standard Deviation 36.3
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 5 morning	49.1 score on a scale Standard Deviation 31.6	36.1 score on a scale Standard Deviation 32.3
Anxiety Rating Using the 100mm Vertical Visual Analog Scale Day 7 afternoon	34.4 score on a scale Standard Deviation 35.8	30.8 score on a scale Standard Deviation 14.8

PRIMARY outcome

Timeframe: 7 days

Population: Includes all patients enrolled who were randomized using an Intention to treat analysis

Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.

Outcome measures

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Duration of Mechanical Ventilatory Support After Study Enrollment	68.7 hours Standard Deviation 58.2	50.3 hours Standard Deviation 52.8

PRIMARY outcome

Timeframe: 7 days

Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.

Outcome measures

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #7 CAM-ICU+	0 participants CAM-ICU+	2 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Study entry CAM-ICU+	15 participants CAM-ICU+	7 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #1 CAM-ICU+	14 participants CAM-ICU+	10 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #2 CAM-ICU+	9 participants CAM-ICU+	5 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #3 CAM-ICU+	8 participants CAM-ICU+	3 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #4 CAM-ICU+	2 participants CAM-ICU+	2 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #5 CAM-ICU+	2 participants CAM-ICU+	2 participants CAM-ICU+
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU) Day #6 CAM-ICU+	0 participants CAM-ICU+	4 participants CAM-ICU+

SECONDARY outcome

Timeframe: 7 days

Population: Not all patients were available for RASS assessment at each time point as some patients were extubated and completed the study, or were withdrawn or died.

The Richmond Agitation-Sedation Scale (RASS) was used to assess the level of alertness and agitation in enrolled patients. Scores range from -5 to +4. RASS 0/zero indicates alert and calm patient. Negative scores (-1 to -5) indicate increasing level of sedation with -5 indicating unarousable. Positive scores indicate increasing agitation (+1 to +4) with +4 indicating a combative patient. For enrolled study patients, RASS score -2 (light sedation) to +1 (restless) was considered in range. We report here the total number of patients assessed as outside the desirable range of RASS score -5 to -3 and +2 to +4 by each ICU study day.

Outcome measures

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #1 : Number of patients assessed	65 Participants	68 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #1 : Number of patients out of range	12 Participants	5 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #2 : Number of patients out of range	7 Participants	5 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #3 : Number of patients assessed	36 Participants	22 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #4 : Number of patients assessed	27 Participants	12 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #5 : Number of patients out of range	2 Participants	3 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #6 : Number of patients out of range	1 Participants	3 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #2 : Number of patients assessed	42 Participants	32 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #3 : Number of patients out of range	6 Participants	3 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #4 : Number of patients out of range	2 Participants	4 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #5 : Number of patients assessed	20 Participants	12 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #6 : Number of patients assessed	17 Participants	10 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #7 : Number of patients assessed	14 Participants	20 Participants
Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS) Day #7 : Number of patients out of range	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Daily Sedation intensity over a 7-day ICU study protocol period

Population: Patients exit the study at various times over the 7-day ICU study period leading to a different number of patients available for analysis on each ICU study day.

Sedation intensity combines the number of sedative doses and the dose amount of any of 9 intravenous (IV) sedative medications (lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine) recorded in the electronic health record, summarized over all patients and time periods each day to obtain medians and quartiles. Each of the 9 sedative drugs administered during each 4-hr period is then assigned a ranking: 0 for drug not used, 1 for the bottom quartile, 2 for the second quartile, 3 for the third, and 4 for the fourth. A score is determined by summing for the 24-hr day over the 6, 4-hour blocks to produce a daily Sedation Intensity Score from 0-36, higher score more intense dosing received of sedative medications.

Outcome measures

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Study entry sedation intensity	10.2 score on a scale Standard Deviation 6.6	9.1 score on a scale Standard Deviation 6.9
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #1 sedation intensity	17.3 score on a scale Standard Deviation 12.0	16.6 score on a scale Standard Deviation 13.1
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #2 sedation intensity	17.4 score on a scale Standard Deviation 13.0	20.7 score on a scale Standard Deviation 15.8
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #3 sedation intensity	17.5 score on a scale Standard Deviation 14.2	19.8 score on a scale Standard Deviation 13.1
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #4 sedation intensity	17.5 score on a scale Standard Deviation 13.3	24.2 score on a scale Standard Deviation 12.7
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #5 sedation intensity	17.9 score on a scale Standard Deviation 15.2	25.7 score on a scale Standard Deviation 18.9
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #6 sedation intensity	16.9 score on a scale Standard Deviation 18.8	22.8 score on a scale Standard Deviation 10.6
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #7 sedation intensity	10.8 score on a scale Standard Deviation 13.8	13.5 score on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Daily Sedation Frequency over a 7-day ICU study protocol period

Population: Patients exit the study at various times over the 7-day ICU study period leading to a different number of patients available for analysis on each ICU study day.

Sedation Frequency is the number of individual intravenous (IV) sedative medication(s) doses administered to patients over each 24-hour day of lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine. Sedation frequency ranges from 0-216 with a higher number indicating more frequent receipt of a sedative medication(s).

Outcome measures

Measure	Control n=81 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Study entry sedation frequency	13.9 count of sedative medication doses Standard Deviation 8.0	13.5 count of sedative medication doses Standard Deviation 7.3
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #1 sedation frequency	24.6 count of sedative medication doses Standard Deviation 15.1	22.9 count of sedative medication doses Standard Deviation 13.5
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #2 sedation frequency	24.3 count of sedative medication doses Standard Deviation 17.2	25.0 count of sedative medication doses Standard Deviation 15.5
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #3 sedation frequency	24.4 count of sedative medication doses Standard Deviation 17.7	24.3 count of sedative medication doses Standard Deviation 14.1
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #4 sedation frequency	25.0 count of sedative medication doses Standard Deviation 16.3	30.2 count of sedative medication doses Standard Deviation 14.8
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #5 sedation frequency	25.9 count of sedative medication doses Standard Deviation 17.9	32.5 count of sedative medication doses Standard Deviation 19.0
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #6 sedation frequency	23.5 count of sedative medication doses Standard Deviation 19.3	27.3 count of sedative medication doses Standard Deviation 10.9
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients. Day #7 Sedation frequency	14.9 count of sedative medication doses Standard Deviation 14.2	16.0 count of sedative medication doses Standard Deviation 10.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Independence in activities of daily living at 3 months and 6 months after hospital discharge over the telephone

Population: Different number of patients responded to the telephone call at each time point .

Physical status will be assessed by the Katz Activities of Daily Living scale to assess basic physical abilities like bathing, feeding with 6 questions. Higher scores of 6 indicates the individual is independent, whereas a score of 0 indicates the individual is very dependent.

Outcome measures

Measure	Control n=39 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale 3 months after discharge	5.1 score on a scale Standard Deviation 1.8	5.6 score on a scale Standard Deviation 1.0
Comparison of Post-ICU Physical Status Using the Katz Activities of Daily Living Scale 6 months after discharge	5.5 score on a scale Standard Deviation 1.2	5.6 score on a scale Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 and 6 months after ICU discharge over the telephone

Population: 3 month PHQ-9

Psychological well-being will be assessed by the Patient Health Questionnaire (PHQ-9) is a 9-item tool that tracks symptoms of major depression. Scores range from 9-36, with higher scores indicating altered psychological well-being.

Outcome measures

Measure	Control n=36 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 3 months after discharge	23.0 score on a scale Standard Deviation 4.3	22.1 score on a scale Standard Deviation 5.2
Comparison of Post-ICU Psychological Well-being Status Using the Patient Health Questionnaire-9 6 months after discharge	23.5 score on a scale Standard Deviation 3.8	23.3 score on a scale Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months and 6 months after ICU discharge over the telephone

Psychological well-being will be assessed with the Posttraumatic Stress Disorder Checklist Event Specific (PCL) to measure symptoms of posttraumatic stress disorder after a stressful life experience of ICU admission. Scores range from 17-85 with higher scores indicating being symptomatic for posttraumatic stress.

Outcome measures

Measure	Control n=38 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-ICU Psychological Well-being Status Using the Posttraumatic Stress Disorder Checklist Event Specific (PCL) Scale	23.8 score on a scale Standard Deviation 7.4	27.7 score on a scale Standard Deviation 15.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone Physical Function Domain

Population: Physical Function at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 (SF-36) at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain	45.4 score on a scale Standard Deviation 29.9	53.8 score on a scale Standard Deviation 29.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone Physical Function Domain

Population: Physical Function at 6 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Physical Function Domain	57.0 score on a scale Standard Deviation 26.6	58.6 score on a scale Standard Deviation 30.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health

Population: Role limitations due to physical health at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=38 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain	22.4 score on a scale Standard Deviation 32.8	43.8 score on a scale Standard Deviation 38.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone Role Limitations Domain due to Physical Health

Population: Role limitations due to physical health at 6 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Role Limitations Domain	39.8 score on a scale Standard Deviation 38.0	44.2 score on a scale Standard Deviation 39.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health

Population: Role limitations due to personal or emotional health at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Personal or Emotional Health Domain	80.2 score on a scale Standard Deviation 32.8	76.2 score on a scale Standard Deviation 33.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone Role Limitations due to Personal or Emotional Health

Population: Role limitations due to personal or emotional health at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using Personal or Emotional Health Domain	78.9 score on a scale Standard Deviation 34.4	71.4 score on a scale Standard Deviation 37.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone Energy/Fatigue Domain

Population: Energy/fatigue at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain	54.3 score on a scale Standard Deviation 19.2	43.6 score on a scale Standard Deviation 26.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone Energy/Fatigue

Population: Energy/fatigue at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Using the Energy/Fatigue Domain	54.2 score on a scale Standard Deviation 22.5	53.8 score on a scale Standard Deviation 20.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone Emotional Well-being

Population: Emotional well-being at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain	83.5 score on a scale Standard Deviation 14.7	80.0 score on a scale Standard Deviation 21.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone Emotional Well-being

Population: Emotional well-being at 6 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Emotional Well-being Domain	81.8 score on a scale Standard Deviation 18.8	83.5 score on a scale Standard Deviation 15.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone social functioning

Population: Social functioning at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Social Functioning Domain	76.4 score on a scale Standard Deviation 22.6	75.9 score on a scale Standard Deviation 27.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone social functioning

Population: Social functioning at 6 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Socia Functioning Domain	77.3 score on a scale Standard Deviation 24.3	72.5 score on a scale Standard Deviation 31.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone bodily pain

Population: Bodily pain at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain	72.3 score on a scale Standard Deviation 25.5	58.1 score on a scale Standard Deviation 27.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone bodily pain

Population: Bodily pain at 6 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 Bodily Pain Domain	71.0 score on a scale Standard Deviation 23.5	61.3 score on a scale Standard Deviation 31.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after ICU discharge over the telephone general health perceptions

Population: General health perceptions at 3 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=37 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=28 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain	52.3 score on a scale Standard Deviation 21.0	51.3 score on a scale Standard Deviation 24.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after ICU discharge over the telephone general health perceptions

Population: General health perceptions at 6 months

Post-intensive care unit health-related quality of life will be assessed by the Short-Form-36 at 3- and 6-months after hospital discharge. The SF-36 tracks how well an individual feels and how well they are able to do their usual activities in eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score defines a more favorable health state scored on a 0-100 range for each of the 8 domain scales.

Outcome measures

Measure	Control n=32 Participants These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=30 Participants These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a basal intravenous infusion of medication (dexmedetomidine) and have access to self-administered bolus doses of dexmedetomidine for anxiety.
Comparison of Post-intensive Care Unit Health-related Quality of Life Using the Short-Form 36 General Health Domain	52.7 score on a scale Standard Deviation 22.0	53.0 score on a scale Standard Deviation 26.9

Adverse Events

Control

Serious events: 5 serious events

Other events: 29 other events

Deaths: 1 deaths

Dexmedetomidine

Serious events: 12 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=81 participants at risk These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 participants at risk These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
Respiratory, thoracic and mediastinal disorders Worsening respiratory failure	2.5% 2/81 • Number of events 2 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	6.2% 5/80 • Number of events 5 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
Cardiac disorders Cardiac arrest	0.00% 0/81 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	2.5% 2/80 • Number of events 2 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
General disorders Device disruption	3.7% 3/81 • Number of events 3 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	2.5% 2/80 • Number of events 2 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
General disorders Persistent agitation	0.00% 0/81 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	3.8% 3/80 • Number of events 3 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.

Other adverse events

Measure	Control n=81 participants at risk These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team	Dexmedetomidine n=80 participants at risk These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Dexmedetomidine: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
Cardiac disorders Hypotension	28.4% 23/81 • Number of events 23 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	27.5% 22/80 • Number of events 22 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
Cardiac disorders Bradycardia	0.00% 0/81 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	2.5% 2/80 • Number of events 2 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
Cardiac disorders Hypertension	1.2% 1/81 • Number of events 1 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	0.00% 0/80 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.
Cardiac disorders Tachycardia	6.2% 5/81 • Number of events 5 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.	0.00% 0/80 • Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.

Additional Information

Dr. Linda L. Chlan, Professor of Nursing

Mayo Clinic

Phone: 507-255-7859

Email: chlan.linda@mayo.edu

Results disclosure agreements

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