Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

Phase 4

Completed

• Conditions: Procedural Sedation
• Interventions: Drug: Dexmedetomidine; Drug: Alfentanil

• Registration Number: NCT02358057
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-28
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-06
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine and Alfentanil	Dexmedetomidine	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.
Dexmedetomidine and Alfentanil	Alfentanil	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.

Primary Outcome Measures

Name	Time	Method
Ramsay score scale	2 hours

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	2 hours