The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Lebanese American University Medical Center

Status and phase: Unknown; Phase 3

Conditions: ICU Patients; Sedation

Treatments: Drug: Dexmedetomidine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04096768

FA2.2016.R2.21/Jun/2019

Details and patient eligibility

About

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

Enrollment: 394 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 2 patient groups, including a placebo group

Dexmedetomidine + Ketamine

Experimental group

Treatment:

Drug: Dexmedetomidine

Drug: Ketamine

Dexmedetomidine + Placebo

Placebo Comparator group

Treatment:

Drug: Dexmedetomidine