Patientes with thoracotomy for pulmonary resection and videolaparoscopic surgery. MedDRA version: 9.1 Level: LLT Classification code 10062043 Term: Lung operation
Conditions
Interventions
Trade Name: FENTATIENIL*EV 5F 5ML 50MCG/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sufentanil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
AZIENDA OSPEDALIERA DI PADOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Patientes with thoracotomy for pulmonary resection: - age80years 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: - age80years old, - surgery duration superior to 4 hours, - renal and liver failure - heart failure NYHA III-IV - psichiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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): | — |
Countries
Italy
Outcome results
None listed