Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

NCT ID: NCT02358057

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-04-30

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.

Conditions

Procedural Sedation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine and 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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Alfentanil

Intervention Type: DRUG

Interventions

Dexmedetomidine

Intervention Type: DRUG

Alfentanil

Intervention Type: DRUG

Other Intervention Names

Dexdor; Precedex; Rapifen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franck Verschuren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St Luc

Other Identifiers

UCL - DexAlf - 1

Identifier Type: -

Identifier Source: org_study_id