Procedural SedationPhase 4NCT02358057
Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?
A Phase 4 study testing Dexmedetomidine and Alfentanil in people with Procedural Sedation, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department. Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Dexmedetomidine and Alfentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:
- The insertion of a chest drain
- Abscess incision and drainage
- Closed reduction of a dislocated joint
Who cannot join
- Patients refusing to participate in the study (refusal to sign the consent form)
- Patients refusing sedation
- Patients unable to participate in the study (consent is impossible to obtain)
- Pregnant women
- The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
- Patients with poor respiratory status determined by:
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- Respiratory rate > 30 / min Oxygen saturation <90%
- Patients with unfavorable hemodynamic status determined by :
- A heart rate > 120 / min A heart rate < 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg
- Patients with contraindication to the use of dexmedetomidine :
- Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease
About this study
Official title: Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?
The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.
Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.
Patients will also receive a dose of alfentanil, 1 minute before the technical act.
- Conditions
- Procedural Sedation
- Being tested
- Dexmedetomidine, Alfentanil
- Keywords
- Deep sedation, Dexmedetomidine, Emergency Service, Hospital
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor, Precedex
AlfentanilDrug
Also called Rapifen
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine and Alfentanil | Experimental | Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.
At time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes.
Patients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes.
Afterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine
Patients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act.
A new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN > 50.
The maximum dose of alfentanil the patient can receive is 5 mcg / kg. Receives: Drug: Dexmedetomidine; Drug: Alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ramsay score scale
Measured: 2 hours
Secondary outcomes (1)
Number of participants with adverse events
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck Verschuren, MD, PhD, Principal investigator, St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358057
- Sponsor's protocol ID
- UCL - DexAlf - 1
- Status last verified
- Jul 2016
- First submitted
- 28 Jan 2015
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?
- ClinicalTrials.gov ID
- NCT02358057
- Acronym / sponsor ID
- UCL - DexAlf - 1
- Conditions
- Procedural Sedation
- Keywords
- Deep sedation, Dexmedetomidine, Emergency Service, Hospital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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 main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.
Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.
Patients will also receive a dose of alfentanil, 1 minute before the technical act.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine and Alfentanil | Experimental | Drug: Dexmedetomidine, Drug: AlfentanilPatients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine. At time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes. Patients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes. Afterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine Patients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act. A new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN > 50. The maximum dose of alfentanil the patient can receive is 5 mcg / kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:
- The insertion of a chest drain
- Abscess incision and drainage
- Closed reduction of a dislocated joint
Key exclusion criteria (11 listed)
- Patients refusing to participate in the study (refusal to sign the consent form)
- Patients refusing sedation
- Patients unable to participate in the study (consent is impossible to obtain)
- Pregnant women
- The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
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 |
|---|---|---|
| DexmedetomidineAlso: Dexdor, Precedex | Drug | Dexmedetomidine and Alfentanil |
| AlfentanilAlso: Rapifen | Drug | Dexmedetomidine and Alfentanil |
Primary outcome
Ramsay score scale
Time frame: 2 hours
1 secondary outcome
Number of participants with adverse events
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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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.
Franck Verschuren, MD, PhD principal investigator
St Luc
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Alfentanil in people with Procedural Sedation, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 11 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: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ramsay score scale (time frame: 2 hours). 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 6 Jul 2016.