DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017