The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety
1 other identifier
interventional
394
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2019
CompletedStudy Start
First participant enrolled
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedFebruary 20, 2020
February 1, 2020
2 years
September 15, 2019
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only
Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only
Within 24 hours of drugs administration
Secondary Outcomes (1)
Measuring the doses of dexmedetomidine and ketamine when combined and the doses of dexmedetomidine when used alone to achieve desired level of sedation
Within 24 hours of drugs administration
Study Arms (2)
Dexmedetomidine + Ketamine
EXPERIMENTALDexmedetomidine + Placebo
PLACEBO COMPARATORInterventions
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lebanese American University Medical Center- Rizk Hospital
Beirut, 00000, Lebanon
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Intensive Care Medicine Physician
Study Record Dates
First Submitted
September 15, 2019
First Posted
September 20, 2019
Study Start
September 16, 2019
Primary Completion
September 16, 2021
Study Completion
December 30, 2021
Last Updated
February 20, 2020
Record last verified: 2020-02