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Alpha-2 Adrenergic Agonist
Patient-Controlled Sedation for Critical Illness
Phase 2 & 3
Recruiting
Led By Linda L Chlan
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is acutely mechanically ventilated during the current hospitalization.
Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months after icu discharge over the telephone
Awards & highlights
Study Summary
This trial is testing whether patients can manage their own sedation while on a ventilator, which may reduce anxiety, time on the ventilator, and occurrence of delirium.
Who is the study for?
This trial is for adults on mechanical ventilators in the ICU who can self-manage sedation with dexmedetomidine, have stable vital signs, and are able to give consent. Excluded are those with severe heart issues, recent heart attacks, acute hepatitis/liver failure, pregnant or lactating women, imminent extubation plans, or conditions preventing button use.Check my eligibility
What is being tested?
The study tests if patients controlling their own sedative therapy with dexmedetomidine while on a ventilator manage anxiety better than standard nurse-administered care. The goal is to see if this leads to shorter ventilation times and less delirium.See study design
What are the potential side effects?
Dexmedetomidine may cause side effects like low blood pressure, slow heart rate (bradycardia), dry mouth, nausea. It's generally considered safe but monitoring for these effects will be part of the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on a breathing machine in the hospital.
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I am currently on or have recently had IV sedation or pain medication.
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I passed the PCS screening and my sedation level is mildly sedated to slightly alert.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 6 months after icu discharge over the telephone
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months after icu discharge over the telephone
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in anxiety using the 100mm vertical visual analog scale
Changes in delirium using the CAM-ICU tool
Changes in duration of days receiving mechanical ventilation after study enrollment
Secondary outcome measures
Comparison of level of arousal and alertness using the Richmond Agitation-Sedation Scale
Comparison of sedative exposure (sedation frequency + sedation intensity) using electronic health record data of intravenous sedative medications.
Other outcome measures
Comparison of immediate post-extubation recollections of ICU using the Intensive Care Experience questionnaire
Comparison of post-ICU functional status using the Functional Activities Questionnaire
Comparison of post-ICU physical status using the Katz Activities of Daily Living scale
+4 moreSide effects data
From 2020 Phase 4 trial • 798 Patients • NCT0200461357%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DexmedetomidineExperimental Treatment1 Intervention
These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.
Group II: ControlActive Control1 Intervention
These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,783 Total Patients Enrolled
17 Trials studying Critical Illness
42,522 Patients Enrolled for Critical Illness
University of MinnesotaOTHER
1,380 Previous Clinical Trials
1,588,555 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,437 Total Patients Enrolled
18 Trials studying Critical Illness
20,943 Patients Enrolled for Critical Illness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or breastfeeding.I am currently on a breathing machine in the hospital.I am about to be taken off a breathing machine.I have not had a recent stroke or uncontrolled seizures.I cannot use a push button device due to paralysis or another condition.I require strong support to help me breathe, including being positioned face down.I do not require high doses of medication to maintain my blood pressure.I or someone authorized can make health decisions for me.I am 18 years old or older.I am currently on or have recently had IV sedation or pain medication.I passed the PCS screening and my sedation level is mildly sedated to slightly alert.You have been assessed with a Richmond Agitation-Sedation Scale (RASS) score of -3, -4, -5, +2, +3, or +4.I have had a heart attack in the last 2 days.I have a slow heartbeat or a specific type of heart rhythm problem.I do not have severe liver problems (bilirubin >5 mg/dL).
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Dexmedetomidine
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is Dexmedetomidine used to help patients?
"While most commonly used to treat the primary condition, Dexmedetomidine is also an effective medication for cyclic vomiting syndrome, intubations, and other conditions."
Answered by AI
How many people are being given this drug as part of the research project?
"That is correct, the listing on clinicaltrials.gov does show that this trial is open and looking for participants. This particular study was posted on November 1st, 2016 with the most recent update happening February 22nd of this year. They are hoping to enroll a total of 228 patients at 2 separate locations."
Answered by AI
Are there any patients still needed for this research?
"Yes, this trial is still looking for patients. It was posted on clinicaltrials.gov on November 1st, 2016 and updated February 22nd, 2022. The trial needs 228 patients from 2 different locations."
Answered by AI
Is there a lot of research available on Dexmedetomidine?
"Currently, 118 studies are underway to research Dexmedetomidine. Out of those active studies, 25 have progressed to Phase 3 clinical trials. The majority of the Karachi-based trials taking place in Sindh; however, there are a total of 222 locations running these sorts of tests."
Answered by AI
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