The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

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

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

Study Overview

• Status: Unknown
• Conditions: ICU Patients; Sedation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Anticipated): 394
• Phase: Phase 3

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 00000
    • Recruiting
    • Lebanese American University Medical Center- Rizk Hospital
    • Contact: Fayez Abillama, MD; Phone Number: 6420 01200800; Email: fayez.abillama@gmail.com
    • Sub-Investigator: Yara Kuyumdjian, Pharm.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine + Ketamine	Drug: Dexmedetomidine; Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients; Drug: Ketamine; Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
Placebo Comparator: Dexmedetomidine + Placebo	Drug: Dexmedetomidine; Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lebanese American University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Anticipated): September 16, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine
• Other Study ID Numbers: FA2.2016.R2.21/Jun/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes