phase of agony, pre-death
Conditions
Interventions
Trade Name: BUSCAPINA Compositum ampollas BOEHRINGER INGELHEIM ESPAÑA
Product Name: Buscapina
Pharmaceutical Form: Solution for injection/infusion
Trade Name: Suero Fisiologico Braun 1 ampolla de 10
Sponsors
Asociación Instituto Biodonostia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient wishes to die at home and your family / carers are able to take care. Accept participation in the study (informed consent will be signed by the patient or family depending on the degree of autonomy of the patient). Over 18 years of age. Diagnosis of malignancy any location terminally ill (prognosis of less than 6 months and life outside of active treatment). 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 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 124
Exclusion criteria
Exclusion criteria: Patient COPD Patient with acute lung edema Patient with acute respiratory infection (aspiration) In another experimental drug treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the effectiveness of treatment with hyoscine N-butylbromide (Buscopan) vs placebo in controlling secretions in agony.;Secondary Objective: Evaluate the effectiveness of preventive treatment of hyoscine N-butylbromide (Buscopan) to avoid the appearance of death rattles. Assess the required dose of hyoscine N-butylbromide (Buscopan) to control of death rattles. Evaluate the treatment time is needed to control the rattle. To evaluate the presence / absence of urinary retention. Number of patients requiring rescue medication due to the agitation.;Primary end point(s): The outcome measure will be depend on the degree of death rattles;Timepoint(s) of evaluation of this end point: The death rattles measured on a audible scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of patients who required rescue medication for anxiety / agitation once induced sedation and initiated treatment. No. of patients who required increased medication intervention (double dose). No patients in the double-blind was broken Final Perception opinion of the caregiver;Timepoint(s) of evaluation of this end point: for all secondary times points are measured with the audible scale | — |
Countries
Spain
Contacts
Public ContactUnidad Ensayo Clínicoº
Asociación Instituto Biodonostia
Outcome results
None listed