The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04096768

Enrollment

394

Registered

2019-09-20

Start date

2019-09-16

Completion date

2021-12-30

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU Patients, Sedation

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

Interventions

DRUGDexmedetomidine

Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients

DRUGKetamine

Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Lebanon

Contacts

Primary ContactFayez Abillama, MD

fayez.abillama@gmail.com01200800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026