Association Between Clinical Effect of Continuous Morphine Administration After Surgery and Pharmacogenetics
Association Between Clinical Effect of Continuous Morphine Administration in Patients After Major Surgery and Pharmacogenetics: Perspective Observational Clinical Study
調査の概要
詳細な説明
研究の種類
連絡先と場所
研究場所
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Pavia、イタリア、27100
- Fondazione IRCCS Policlinico San Matteo
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Group A
Homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene
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The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation. At the exit of the operative compartment patients will have an continuous infusion for 48h with morphine chlorhydrate 0,02 mg/kg/h. Moreover, a rescue dose therapy will be prescribed with ketoprofen 160 mg or ketorolac 30mg (in case of allergy acetaminophene 1g) if NRS<4 maximum x 3 daily. Postoperative analgesic treatment is lasting 48h for each patient (between starting of the infusion (T0) and the following 48h).
他の名前：
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Group B
Both homozygous and heterozygous patients for the less frequent allele of the polymorphism A118G of OPRM1 gene
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The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation. At the exit of the operative compartment patients will have an continuous infusion for 48h with morphine chlorhydrate 0,02 mg/kg/h. Moreover, a rescue dose therapy will be prescribed with ketoprofen 160 mg or ketorolac 30mg (in case of allergy acetaminophene 1g) if NRS<4 maximum x 3 daily. Postoperative analgesic treatment is lasting 48h for each patient (between starting of the infusion (T0) and the following 48h).
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：first 24 h after surgery
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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%).
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first 24 h after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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痛みの中央値に向けた遺伝子座 OPRM1、COMT、UGTs、ESR1 の変異
時間枠：手術後24時間の間
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NRS ≤ 4 の患者と NRS > 4 の患者の両方における 24 時間以内に少なくとも 1 回発生した、OPRM1、COMT、UGT、ESR1 遺伝子座における変異の頻度。
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手術後24時間の間
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Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
時間枠：period between 24 - 48 h postsurgery
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Frequency of the variants at the loci OPRM1, COMT, UGTs, ESR1, both in patients with NRS ≤4 and in those having NRS >4 at least once during the period between 24-48 hours postsurgery.
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period between 24 - 48 h postsurgery
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Pharmacokinetics of morphine during continuous administration after surgery
時間枠：48 h after surgery
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Pharmacokinetic study of both morphine and its principal active and/or toxic metabolites (M3G and M6G).
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48 h after surgery
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Detection of the possible side effects.
時間枠：72 h postopratively
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Detection of the possible side effects after continuous morphine administration
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72 h postopratively
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Detection of the association between M3G/M6G ratio and polymorphisms of UGTs
時間枠：within 72 h postoperatively
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Detection of the association between M3G/M6G ratio and polymorphisms of UGTs and its possible side effects.
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within 72 h postoperatively
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協力者と研究者
捜査官
- 主任研究者：Massimo Allegri, MD、IRCCS Policlinico San Matteo
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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