The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Phase 3

• Conditions: Sedation; ICU Patients
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT04096768
• Lead Sponsor: Lebanese American University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-15
• Study Start: 2019-09-16
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Primary Completion: 2021-09-16
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 394

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine + Placebo	Dexmedetomidine	-
Dexmedetomidine + Ketamine	Dexmedetomidine	-
Dexmedetomidine + Ketamine	Ketamine	-

Primary Outcome Measures

Name	Time	Method
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	Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only

Secondary Outcome Measures

Name	Time	Method
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	Measuring the doses of dexmedetomidine and ketamine when combined and the dose of dexmedetomidine when used alone to achieve desired level of sedation

Trial Locations

Locations (1)

Lebanese American University Medical Center- Rizk Hospital; 🇱🇧 Beirut, Lebanon