Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Completed; Phase 4

Conditions: Procedural Sedation

Treatments: Drug: Alfentanil; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02358057

UCL - DexAlf - 1

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Dexmedetomidine and Alfentanil

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Alfentanil