Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?
Information source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Procedural Sedation
Intervention: Dexmedetomidine (Drug); Alfentanil (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain Official(s) and/or principal investigator(s): Franck Verschuren, MD, PhD, Principal Investigator, Affiliation: St Luc
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.
Clinical Details
Official title: Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ramsay score scale
Secondary outcome: Number of participants with adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 2015
Last updated: April 9, 2015
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