The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

NCT ID: NCT04096768

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-12-30

Brief Summary

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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

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Conditions

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ICU Patients Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dexmedetomidine + Ketamine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Ketamine

Intervention Type DRUG

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

Dexmedetomidine + Placebo

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Ketamine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lebanese American University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Fayez Abillama, MD

Intensive Care Medicine Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lebanese American University Medical Center- Rizk Hospital

Beirut, , Lebanon

Site Status RECRUITING

Countries

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Lebanon

Central Contacts

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Fayez Abillama, MD

Role: CONTACT

01200800 ext. 6420

Facility Contacts

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Fayez Abillama, MD

Role: primary

01200800 ext. 6420

Other Identifiers

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FA2.2016.R2.21/Jun/2019

Identifier Type: -

Identifier Source: org_study_id

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