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The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

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ClinicalTrials.gov Identifier: NCT04096768
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Fayez Abillama, MD, Lebanese American University Medical Center

Tracking Information
First Submitted Date  ICMJE September 15, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE September 16, 2019
Estimated Primary Completion Date September 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Measuring the doses of dexmedetomidine and ketamine when combined and the doses of dexmedetomidine when used alone to achieve desired level of sedation [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
Official Title  ICMJE Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • ICU Patients
  • Sedation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Dexmedetomidine + Ketamine
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Ketamine
  • Placebo Comparator: Dexmedetomidine + Placebo
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
394
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date September 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fayez Abillama, MD 01200800 ext 6420 fayez.abillama@gmail.com
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04096768
Other Study ID Numbers  ICMJE FA2.2016.R2.21/Jun/2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fayez Abillama, MD, Lebanese American University Medical Center
Study Sponsor  ICMJE Lebanese American University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lebanese American University Medical Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP