The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Study Overview
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Brief Summary
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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

Official Title
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Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety

Conditions
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ICU Patients, Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine + Ketamine<br> | Drug: Dexmedetomidine<br>* Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients<br>Drug: Ketamine<br>* Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients<br>|
| Placebo Comparator: Dexmedetomidine + Placebo<br> | Drug: Dexmedetomidine<br>* Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the doses of dexmedetomidine and ketamine when combined and the doses of dexmedetomidine when used alone to achieve desired level of sedation | Measuring the doses of dexmedetomidine and ketamine when combined and the dose of dexmedetomidine when used alone to achieve desired level of sedation | Within 24 hours of drugs administration |