Effect of IV Infusion of Lidocaine Compared to IV Infusion of Dexmedetomidine on Proinflammatory Cytokines
キーワード
概要
説明
Cancer patients who undergo surgery face many sources of stress. Surgery causes major cytokine and neuroendocrinal changes like increased levels of catecholamine and steroid hormones and other metabolic consequences .This stress response is considered a defense mechanism important for developing resistance to noxious insults.
The cytokine cascade caused by surgical stimulation is complex with various effects on the injured host. Increased production of proinflammatory cytokines from the site of injury causes many systemic changes such as metabolic derangements and hemodynamic instability. Some released cytokines like tumor necrosis factor alpha (TNF-α) and Interleukin 6(IL-6) can cause long lasting hyperalgesia. These proinflammatory cytokines change pain signal transmission through cytokine induced release of some neuroactive substances like nitric oxide, oxygen free radicals and excitatory amino acids. On the other hand anti-inflammatory cytokines are also released during inflammation to counteract these effects and keep balance.
Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that has sedative, analgesic, anesthetic-sparing properties with no respiratory depression. Its anti-inflammatory effects are being studied.
Intravenous lidocaine can be used in management of chronic pain. Lidocaine has anti-inflammatory properties and is capable of reducing postoperative analgesic requirements and the length of hospitalization.
The effect of both drugs on proinflammatory cytokines and stress response will be assessed
日付
| 最終確認済み: | 09/30/2019 |
| 最初に提出された: | 09/23/2019 |
| 提出された推定登録数: | 10/29/2019 |
| 最初の投稿: | 10/31/2019 |
| 最終更新が送信されました: | 10/29/2019 |
| 最終更新日: | 10/31/2019 |
| 実際の研究開始日: | 01/01/2018 |
| 一次完了予定日: | 11/30/2019 |
| 研究完了予定日: | 12/31/2019 |
状態または病気
介入/治療
Drug: dexmedetomidine
Drug: lidocaine
Drug: placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: dexmedetomidine dexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively | Drug: dexmedetomidine a loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery. |
| Active Comparator: lidocaine Lidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively | Drug: lidocaine a loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery. |
| Placebo Comparator: placebo saline infusion will be administered preoperatively and continued intraoperatively | Drug: placebo 50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - American society of anesthesia (ASA) Physical Status classification: ASA II physical status. - Age between 18 to 60 years old. - Patients who will undergo major pelviabdominal surgery. Exclusion Criteria: - Patient refusal. - Allergy to local anesthetics. - Cognitive disorders. - uncontrolled diabetes or hypertension. |
結果
主な結果の測定
1. change in inflammatory mediators [preoperative (baseline), immediately postoperative and 24 hours postoperative]
2. change in serum level of insulin and lactate [preoperative (baseline), immediately postoperative and 24 hours postoperative]
二次的な結果の測定
1. Rescue analgesia [1st 24 hours]
2. Visual analogue scale (VAS) score for pain [at 0 hour, 2 hour,6 hour, 12 hour and 24 hour]
3. postoperative morphine requirements [1st 24 hours]
