Status:
UNKNOWN
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
Lead Sponsor:
Lebanese American University Medical Center
Conditions:
ICU Patients
Sedation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy
Eligibility Criteria
Inclusion
- Age between 18-80 years old
- Admitted to Intensive care unit at LAUMCRH
- Need for sedation for at least 24 hours
- Informed Consent Form signed by patient or surrogate
Exclusion
- Pregnant patients
- 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
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT04096768
Start Date
September 16 2019
End Date
December 30 2021
Last Update
February 20 2020
Active Locations (1)
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1
Lebanese American University Medical Center- Rizk Hospital
Beirut, Lebanon, 00000