Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02358057

Enrollment

Registered

2015-02-06

Start date

2015-02-28

Completion date

2016-04-30

Last updated

2016-07-06

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

Conditions

Procedural Sedation

Keywords

Deep sedation, Dexmedetomidine, Emergency Service, Hospital

Brief 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 injection of dexmedetomidine. Patients will also receive a dose of alfentanil, 1 minute before the technical act.

Interventions

DRUGDexmedetomidine

DRUGAlfentanil

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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: 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

Design outcomes

Primary

Measure	Time frame
Ramsay score scale	2 hours

Secondary

Measure	Time frame
Number of participants with adverse events	2 hours

Outcome results

None listed

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