patients affected by patologies to be submitted to endoscopic investigation MedDRA version: 9.1 Level: LLT Classification code 10014805 Term: Endoscopy
Conditions
Interventions
Trade Name: ULTIVA
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Remifentanil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients aged more than 18 years old; ASA physical status I-II;patients candidate for diagnostic or operative intervention of endoscopic type on gastrointestinal tract. 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: patients aged under 18 years old; pregnancy fenmale patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to define the adequate dosage of remifentanil and to define if PCSA can produce an adequate analgesic effect with a speeder recover without increase of the incidence of adverse events.;Secondary Objective: to define the adequate dosage of remifentanil and to define if PCSA can produce an adequate analgesic effect with a speeder recover without increase of the incidence of adverse events.;Primary end point(s): patient`s satisfaction expressed by cents of VAs with SD of 12/10 (inferred by previous study of our group) | — |
Countries
Italy
Outcome results
None listed