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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01233219 |
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Date of registration:
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02/11/2010 |
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Primary sponsor: |
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Public title:
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Association Between Clinical Effect of Continuous Morphine Administration After Surgery and Pharmacogenetics
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Scientific title:
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Association Between Clinical Effect of Continuous Morphine Administration in Patients After Major Surgery and Pharmacogenetics: Perspective Observational Clinical Study |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01233219 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Italy
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Contacts
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Name:
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Massimo Allegri, MD |
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Address:
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Telephone:
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00390382 |
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Email:
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m.allegri@smatteo.pv.it |
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Affiliation:
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Name:
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Massimo Allegri, MD |
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Address:
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Telephone:
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0039038250 |
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Email:
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m.allegri@smatteo.pv.it |
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Affiliation:
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Name:
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Massimo Allegri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS Policlinico San Matteo |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Males and females over 18 years, under 75 years, scheduled for postoperative pain
control with continuous 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anesthesia
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Surgery
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Intervention(s)
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Drug: morphine chlorhydrate
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Primary Outcome(s)
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Assessment of the rescue doses in the two groups homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene; group B: both homozygous and heterozygous patients for the less frequent allele
[Time Frame: first 24 h after surgery]
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Secondary Outcome(s)
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Detection of the association between M3G/M6G ratio and polymorphisms of UGTs
[Time Frame: within 72 h postoperatively]
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Detection of the possible side effects.
[Time Frame: 72 h postopratively]
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Pharmacokinetics of morphine during continuous administration after surgery
[Time Frame: 48 h after surgery]
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Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
[Time Frame: during 24 h postsurgery]
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Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
[Time Frame: period between 24 - 48 h postsurgery]
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Secondary ID(s)
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PT-SM-08-MorfinaContinua-Gene
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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