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Completed

NCT Number: NCT02358057

Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

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.

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Key information

Conditions

Procedural Sedation Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Other names: Dexdor, Precedex

alfentanil

Drug

Other names: Rapifen

Primary outcomes

  1. Ramsay score scale

    Time frame: 2 hours

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2015
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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