Sperimental, controlled, randomized single blind study. Sufentanil vs fentanyl in patientes with thoracotomy for pulmonary resection and videolaparoscopic surgery. - Sufentanil vs Fentanyl in thoracotomy
- Conditions
- Patientes with thoracotomy for pulmonary resection and videolaparoscopic surgery.MedDRA version: 9.1Level: LLTClassification code 10062043Term: Lung operation
- Registration Number
- EUCTR2007-005544-24-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PADOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patientes with thoracotomy for pulmonary resection:
age 18-80 years old;
ASA classes: I,II,III;
surgery duration higher 2 hours;
epidural catheter beetween T3 and T8.
Patientes with videolaparoscopic surgery:
age 18-80 years old;
ASA classes: I,II,III.
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
Patientes with thoracotomy for pulmonary resection:
- age< 18 years old and age>80years old,
- surgery duration inferior to 2 hours, - ASA class IV,
- blood loss > 0.5 liter,
- difficulties with epidural catheter,
- renal and liver failure
- heart failure NYHA III-IV
- psichiatric disorders
Patientes with videolaparoscopic surgery:
- age< 18 years old and age>80years old,
- surgery duration superior to 4 hours,
- renal and liver failure
- heart failure NYHA III-IV
- psichiatric disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy and safety of sufentanil vs fentanyl during anesthesia in thoracotomy for pulmonary resection and in videolaparoscopic surgery.;Secondary Objective: To estimate if sufentanil is responsable of a better analgesia in post surgery time.;Primary end point(s):
- Secondary Outcome Measures
Name Time Method