跳至主要内容
临床试验/NCT01233219
NCT01233219撤回不适用

Association Between Clinical Effect of Continuous Morphine Administration in Patients After Major Surgery and Pharmacogenetics: Perspective Observational Clinical Study

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
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

研究概览

简要总结

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 treatment with morphine.

详细描述

Valuation of the rescue doses 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 frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both homozygous and heterozygous patients for the less frequent allele (about 20%).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group A

Homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene

干预措施: morphine chlorhydrate (Drug)

Group B

Both homozygous and heterozygous patients for the less frequent allele of the polymorphism A118G of OPRM1 gene

干预措施: morphine chlorhydrate (Drug)

结局指标

主要结局

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

时间窗: first 24 h after surgery

Valuation of the rescue doses 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 frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both homozygous and heterozygous patients for the less frequent allele (about 20%).

次要结局

  • Pharmacokinetics of morphine during continuous administration after surgery(48 h after surgery)
  • Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure(period between 24 - 48 h postsurgery)
  • Detection of the possible side effects.(72 h postopratively)
  • Detection of the association between M3G/M6G ratio and polymorphisms of UGTs(within 72 h postoperatively)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Allegri

MD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

Loading locations...

相似试验