Confronto degli effetti di due sedativi, la dexmedetomidina e il propofol, in pazienti che hanno bisogno di ricominciare a respirare senza un macchinario e che hanno difficolta' a farlo.

• Register: EUCTR
• Last refreshed on: 19 May 2014
• Main ID: EUCTR2011-001490-40-IT
• Date of registration: 12/03/2012
• Prospective Registration: Yes
• Primary sponsor: ORION CORPORATION ORION PHARMA
• Public title: Confronto degli effetti di due sedativi, la dexmedetomidina e il propofol, in pazienti che hanno bisogno di ricominciare a respirare senza un macchinario e che hanno difficolta' a farlo.
• Scientific title: Comparative evaluation of the effects of dexmedetomidine and propofol on patient/ventilator interaction in difficult-to-wean mechanically ventilated patients; a prospective, open, randomised, multicentre study. - DoVeS
• Date of first enrolment: 03/04/2012
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001490-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Italy

Contacts

• Name: Clinical Trials Information Desk
• Affiliation: Orion Corporation

• Name: Clinical Trials Information Desk
• Affiliation: Orion Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
•Written informed consent obtained from the patient. •18 years or older. •Patients who have failed one weaning trial. •Receiving propofol as a sole agent for continuous sedation (minimum 12 hours) with target sedation level Richmond Agitation-Sedation Scale (RASS) +1 to -2 (must be in target at randomisation). •Intubated and mechanically ventilated in the ICU for more than 24 hours. •Patient has nasogastric (NG)/feeding tube in-situ.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
•Patients who have failed more than one weaning trial. •Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury. •Uncompensated acute circulatory failure at the time of randomisation (severe hypotension with mean arterial pressure less than 55 mmHg despite volume and vasopressors). •Severe bradycardia (heart rate [HR] less than 50 bpm). •AV conduction block II-III (unless pacemaker installed). •Unstable angina or acute myocardial infarction. •Severe hepatic impairment (bilirubin more than 101 ?mol/l). •Need for muscle relaxation at the time of randomisation (could only be used for intubation and initial stabilisation). •Acute renal failure requiring dialytic treatment of all types. •Pregnancy or breastfeeding. •Patients with tracheostomy. •Use of centrally acting alpha-2 agonists or antagonists (e.g. clonidine, titzanidine, apraclonidine and brimonidine) within 24 hours prior to randomisation. •Patients expected to have treatment withdrawn or withheld due to poor prognosis. •Patients unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or amyotrophic lateral sclerosis). •Received any investigational drug within the preceding 30 days. •Concurrent participation in any other interventional study (any study in which patients are allocated to different treatment groups and/or non-routine diagnostic or monitoring procedures are performed). •Previous participation in this study. •Any other condition which, in the investigator’s opinion, could make it detrimental for the patient to participate in the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients requiring mechanical ventilation and sedation in the ICU
MedDRA version: 14.1 Level: PT Classification code 10039897 Term: Sedation System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Intervention(s)

Product Name: Dexmedetomidine
Product Code: NA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Propofol-Lipuro 20 mg/ml
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: The primary objective is to investigate effects of dexmedetomidine on diaphragmatic neural activity (EAdi) over 24 hours after starting study treatment in difficult to wean mechanically ventilated patients.

Secondary Objective: • to investigate effects of dexmedetomidine on other aspects of patient/ventilator interaction and respiratory pattern over 24 hours after starting study treatment; • to describe effects of dexmedetomidine on time to extubation, duration of mechanical ventilation and depth of sedation during the study; • to evaluate the safety of dexmedetomidine during the study.

Primary end point(s): Asynchrony index (AI), defined as the total number of asynchronies as a proportion of the total number of respiratory efforts.

Timepoint(s) of evaluation of this end point: 0.5, 1, 2, 6, 12, 18 and 24 hours after starting study treatment.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 0.5, 1, 2, 6, 12, 18 and 24 hours after randomisation or as appropriate

Secondary end point(s): - Other neural parameters; - Respiratory parameters; - Aterial blood gases; - Time to extubation; - Duration of mechanical ventilation; - Sedation variables; - Use of opioids; - Duration of ICU stay

Secondary ID(s)

3005019

Source(s) of Monetary Support

Orion Corporation