Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

NCT02358057 | Completed Phase 4 DMC

• 1 other identifier: UCL - DexAlf - 1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

Deep sedation; Dexmedetomidine; Emergency Service, Hospital

Outcome Measures

Primary Outcomes (1)

• Ramsay score scale

  2 hours

Secondary Outcomes (1)

• Number of participants with adverse events

  2 hours

Study Arms (1)

Dexmedetomidine and Alfentanil

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Alfentanil

Interventions

Dexmedetomidine DRUG

Also known as: Dexdor, Precedex

Dexmedetomidine and Alfentanil

Alfentanil DRUG

Also known as: Rapifen

Dexmedetomidine and Alfentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

MeSH Terms

Conditions

Emergencies

Interventions

Dexmedetomidine; Alfentanil

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Franck Verschuren, MD, PhD

  St Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07