Remifentanil administered by controlled tecnique PCSA by patients versus Meperidina administered by physician for diagnostic and operative endoscopic procedures. - ND
Phase 1
- Conditions
- patients undergoing diagnostic or operative procedures of endoscopic type with planned sadationMedDRA version: 6.1Level: SOCClassification code 10017947
- Registration Number
- EUCTR2007-003072-19-IT
- Lead Sponsor
- OSPEDALE S. RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
patients aged more than 18 years old undergoing diagnostic and operative procedures of endoscopic type on gastroenteric tract for which is planned a sedation.
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
patients aged less than 18 anni
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events;Secondary Objective: To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events.;Primary end point(s): To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events
- Secondary Outcome Measures
Name Time Method