The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
NCT ID: NCT04096768
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
394 participants
INTERVENTIONAL
2019-09-16
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Dexmedetomidine + Ketamine
Dexmedetomidine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Ketamine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Dexmedetomidine + Placebo
Dexmedetomidine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Interventions
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Dexmedetomidine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Ketamine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Eligibility Criteria
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Inclusion Criteria
* Admitted to Intensive care unit at LAUMCRH
* Need for sedation for at least 24 hours
* Informed Consent Form signed by patient or surrogate
Exclusion Criteria
* At risk of increased intracranial pressure
* Aortic dissection
* Acute coronary syndrome
* Hypertension (SBP \> 180 mmHg)
* Chronic alcoholism
* Acute alcohol intoxication
* Alcohol withdrawal
* Refractory status epilepticus
* History of psychiatric disorder
* Known allergy or contraindication to use of dexmedetomidine or ketamine
* Baseline hypotension (MAP\<65 mmHg)
* Baseline bradycardia (HR\<48 bpm)
* Patients receiving neuromuscular blocking agents
* Patients requiring deep sedation as determined by the ICU attending
18 Years
80 Years
ALL
No
Sponsors
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Lebanese American University Medical Center
OTHER
Responsible Party
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Fayez Abillama, MD
Intensive Care Medicine Physician
Locations
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Lebanese American University Medical Center- Rizk Hospital
Beirut, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FA2.2016.R2.21/Jun/2019
Identifier Type: -
Identifier Source: org_study_id
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