Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

Procedural Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358057
• Other study ID #: UCL - DexAlf - 1
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2015
• Last updated: July 5, 2016
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical 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 injection of dexmedetomidine.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Procedural Sedation

Intervention

Drug:
• Dexmedetomidine

• Alfentanil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ramsay score scale		2 hours	Yes
Secondary	Number of participants with adverse events		2 hours	Yes