ICU PatientsPhase 3NCT04096768
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
A Phase 3 study testing Dexmedetomidine and Ketamine in people with ICU Patients and Sedation, run by Lebanese American University Medical Center at 1 site in Lebanon.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICU Patients, Sedation
- What is being tested?
- Dexmedetomidine and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 1 siteLebanon
- Study dates
- 16 Sep 2019to 30 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant patients
- At risk of increased intracranial pressure
- Aortic dissection
- Acute coronary syndrome
- Hypertension (SBP > 180 mmHg)
- Chronic alcoholism
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Lebanese American University Medical Center- Rizk Hospital
Beirut, 00000
Fayez Abillama, MD, 01200800 ext. 6420, fayez.abillama@gmail.com
Yara Kuyumdjian, Pharm.D
About this study
Official title: Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety
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
- Conditions
- ICU Patients, Sedation
- Being tested
- Dexmedetomidine, Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
KetamineDrug
Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine + Ketamine | Experimental | Not described Receives: Drug: Dexmedetomidine; Drug: Ketamine |
| Dexmedetomidine + Placebo | Placebo comparator | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours of drugs administration
Secondary outcomes (1)
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
Measured: Within 24 hours of drugs administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start16 Sep 2019
- Primary completion16 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese American University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fayez Abillama, MD, Lebanese American University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096768
- Sponsor's protocol ID
- FA2.2016.R2.21/Jun/2019
- Status last verified
- Feb 2020
- First submitted
- 15 Sep 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety
- ClinicalTrials.gov ID
- NCT04096768
- Acronym / sponsor ID
- FA2.2016.R2.21/Jun/2019
- Conditions
- ICU Patients, Sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Lebanese American University Medical CenterUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 16 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine + Ketamine | Experimental | Drug: Dexmedetomidine, Drug: Ketamine |
| Dexmedetomidine + Placebo | Placebo comparator | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Pregnant patients
- At risk of increased intracranial pressure
- Aortic dissection
- Acute coronary syndrome
- Hypertension (SBP > 180 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineComparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients | Drug | Dexmedetomidine + Ketamine, Dexmedetomidine + Placebo |
| KetamineComparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients | Drug | Dexmedetomidine + Ketamine |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Ketamine in people with ICU Patients and Sedation, run by Lebanese American University Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fayez Abillama, MD (01200800 ext. 6420, fayez.abillama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.