Sperimental controlled and randomized in singol blind study.Use of continuous epidural ketamina in patients submitted to toracotomy for pulmonary resection. - continuous epidural ketamina in patients submitted to toracotomy
- Conditions
- pulmonary resectionMedDRA version: 9.1Level: SOCClassification code 10038738
- Registration Number
- EUCTR2008-001236-13-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PADOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- toracotomy
- age 18-75 years old
- ASA Class I,II,III
- duration of operation > 2 hours
- epidural cateterism in T3-T5
- BMI< or = 30
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
- age <18 - >75 years old
- ASA Class IV
- duration of operation < 2 hours
- difficulty in epidural cateterism
- BMI > 30
- hematic loss > 0.5 l
- renal, hepatic and cardiac (NYHA III-IV) failur
- psychiatric disorders, use of psychiatric drugs or abuse of drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Smaller intraoperatory use of Fentanyl, better analgesic covering in immediatly post-operatory time and at a distance( smaller use of analgesic drugs in the first two hours from chirurgy and better quality of analgesia);Primary end point(s): Safety and analgesic covering intra e post toracotomy for pulmonary resection;Main Objective: Safety and analgesic covering intra e post toracotomy for pulmonary resection.
- Secondary Outcome Measures
Name Time Method