Status:
COMPLETED
Association Between Clinical Effect of Morphine With PCA After Surgery and Pharmacogenetics
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Anesthesia
Surgery
Eligibility:
All Genders
18-75 years
Brief Summary
Identification of the genetic polymorphisms that could be correlated either with a better clinical response or with a major predisposition of patients to develop tolerance and/or side effects to the t...
Detailed Description
Valuation of the medium morphine dose (mg/kg/die) necessary to maintain NRS\<4 in the first 24 hours post-surgery in the two groups of patients, A e B. Group A: homozygous patients for the more freque...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Males and females over 18 years, under 75 years, scheduled for postoperative pain control by PCA morphine administration
- HIV negative
- Classification American Society of Anesthesiologists (ASA) I: without systemic disease
- Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
- Undergoing abdominal and urologic major surgery (neither urgent nor emergency surgery)
- Signed informed consent
- Exclusion criteria:
- Usual assumption of analgesic opioids
- Cognitive alterations nor mental retardation
- Severe hepatic/renal insufficiency (cholinesterase \<3000 mU/ml, total bilirubinaemia \<2 mg/dl and creatininaemia \<1.2 mg/dl)
- Inpatients in intensive therapy, either with sedation and/or mechanic ventilation.
- Allergies to morphine and derivates
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT01233752
Start Date
July 1 2010
End Date
July 1 2013
Last Update
July 19 2013
Active Locations (2)
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1
Azienda Ospedaliera San Gerardo
Monza, Italy, 20052
2
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100