The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096768
• Other study ID #: FA2.2016.R2.21/Jun/2019
• Status: Recruiting
• Phase: Phase 3
• Start date: September 16, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2020
• Source: Lebanese American University Medical Center
• Contact: Fayez Abillama, MD
• Phone: 01200800
• Email: fayez.abillama[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 394
• Est. completion date: December 30, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ICU Patients
• Sedation

Intervention

Drug:
• Dexmedetomidine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
• Ketamine
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients

Locations

Country	Name	City	State
Lebanon	Lebanese American University Medical Center- Rizk Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Lebanese American University Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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