analgo-sedation in mechanically ventilated patients MedDRA version: 9.1 Level: LLT Classification code 10002182 Term: Analgesia
Conditions
Interventions
Trade Name: SERENASE*IM IV 5F 5MG 2ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Haloperidol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ) need for sedation and for mechanical ventilation through an endotracheal tube for more than 48 hours, b) ability to tolerate assisted ventilation. This latter criterion will be evaluated with a test with pressure support ventilation (ventilatory settings: pressure support 15 cmH2O and positive end-expiratory pressure 5 cmH2O) for 30 minutes. The test will be considered passed if the patient will maintain a respiratory rate 6 mL/Kg and hemodynamic stability. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) age lower than 50 or higher than 80 years; b) women in fertile age; c) neurologic diseases (e.g., seizures), porphyria, hyperthyroidism; d) actual treatment with lithium, amiodarone, or tricyclic antidepressants; e) arrhythmias or corrected QT > 470 msec; f) Body Mass Index > 30.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess whether the addition of haloperidol to a sedation with intravenous infusion of propofol and remifentanil allows for the reduction of propofol needs, while maintaining an adequate level of sedation.;Secondary Objective: a) to evaluate whether the addition of haloperidol, through a better control of delirium and anxiety, allows for a faster achievement of criteria for weaning from mechanical ventilation (rapid shallow breathing index) and for a better respiratory confort, b) to assess whether haloperidol increases the time interval during which patients are kept alert in the daytime (Response Subscore of Comfort Scale 0 or -1), c) to assess safety of the addition of haloperidol to the sedative regimen.;Primary end point(s): to assess whether the addition of haloperidol to a sedation with intravenous infusion of propofol and remifentanil allows for the reduction of propofol needs, while maintaining an adequate level of sedation. | — |
Countries
Italy
Outcome results
None listed