patients submitted to a thoracotomy MedDRA version: 9.1 Level: SOC Classification code 10038738
Conditions
Interventions
Trade Name: SUFENTANIL HAM
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Sufentanil
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number
Sponsors
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent; Age more then 60 and less then 80 years old; ASA I,II,III; Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known allergy to local anaesthetics and/or opiates; Abnormal Coagulation test; Running infections; Renal Failure; Neurological or psychiatric disorders; VEMS, CFV, FEV1, DLCO, < 60% of normal value; Supraventricula tachy-arrhythmias history; Patients undergoing to pneumonectomy; Heart failure history; Insuline Dependent Diabetes Mellitus history; Patients receiving chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate in a double blanded randomized clinical trials the influence of the continous epidural infusion of local anesthetic on the incidence of supraventricular arrhythmias in patients who underwent to thoracotomy.;Secondary Objective: to evaluate the quality of the post-operative analgesia after thoracotomy;Primary end point(s): evaluation of Hemodynamic status, Analgesia Quality, Evaluation of the motion, Postoperative sedation scale, Blood parameters changes | — |
Countries
Italy
Outcome results
None listed