Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery
キーワード
概要
説明
Postoperative pulmonary complications continue to be one of the main causes of morbidity, mortality and increase in hospital stay in patients undergoing surgical procedures requiring anesthesia. Its incidence in lung resection surgery is greater than in other non-cardiac major surgeries due to damage of structures related to respiratory function.
Furthermore, during lung resection surgery there is an exaggerated pulmonary inflammatory response related to the use of one-lung ventilation and / or the lung damage produced by the collapse of the operated lung as well as the surgical manipulation itself.
Recently, in a clinical trial on 180 patients (NCT 02168751), our researcher group observed that the attenuation of the pulmonary inflammatory response through the use of halogenated anesthetic agents, was related to a decrease in the appearance of postoperative pulmonary complications after lung resection surgery. In addition, the presence, in bronchoalveolar lavages, of elevated levels of tumor necrosis factor-alpha, interleukine(IL)-6 and the IL-6 / IL10 ratio were independent predictors of the risk of developing postoperative pulmonary complications.
Lidocaine is a local anesthetic that blocks nerve conduction by blocking sodium channels. In addition it has been known for experimental and clinical studies of its immunomodulatory properties.
Clinical studies performed in different surgeries show that a continuous intravenous infusion of lidocaine during surgery is associated with a lower inflammatory response assessed by monitoring plasma cytokines, as well as less postoperative pain, a shorter duration of postoperative paralytic ileus and a early hospital discharge.
Currently, there is no clinical study that has evaluated the role of intravenous lidocaine on the pulmonary inflammatory response and the subsequent lung damage that inevitably occurs during lung resection surgery with periods of one lung ventilation.
Currently, some experts are proposing the replacement of thoracic epidural and paravertebral analgesia by the intravenous infusion of lidocaine and minor analgesics, for fast-track programs, based on their analgesic and anti-inflammatory capacity and on avoiding the risks inherent in the insertion of an epidural or paravertebral catheter.
Hypothesis: The administration of intravenous or paravertebral lidocaine during lung resection surgery attenuates the exaggerated inflammatory response that inevitably occurs in this surgical intervention. The lower expression of pro-inflammatory mediators will be associated with a lower rate of postoperative complications that are related to the perioperative inflammatory process.
日付
| 最終確認済み: | 06/30/2020 |
| 最初に提出された: | 03/25/2019 |
| 提出された推定登録数: | 04/03/2019 |
| 最初の投稿: | 04/04/2019 |
| 最終更新が送信されました: | 07/26/2020 |
| 最終更新日: | 07/27/2020 |
| 実際の研究開始日: | 01/27/2019 |
| 一次完了予定日: | 05/27/2021 |
| 研究完了予定日: | 11/27/2021 |
状態または病気
介入/治療
Drug: Lidocaine
Drug: no lidocaine
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Lidocaine IV Group 1: intravenous lidocaine and paravertebral saline (SF). In this group during intraoperative anesthetic maintenance, a continuous intravenous infusion of lidocaine at 1.5mg/kg/h until the end of surgery and perfusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1ml/kg/h will be administered. | |
| Experimental: Lidocaine PV Group 2: intravenous SF and paravertebral lidocaine. During anesthesia maintenance, a continuous intravenous infusion of 0.9% SF and an infusion of 2% lidocaine will be administered through the intraoperative paravertebral catheter at a rate of 0.1 ml/kg/h. | |
| Active Comparator: no lidocaine Group 3: intravenous remifentanil and paravertebral SF. During the maintenance of anesthesia, a continuous intravenous infusion of remifentanil at a rate of 0.1 mg/kg/min until the end of surgery and an infusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1 ml / kg / h. | Drug: no lidocaine intravenous remifentanil |
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: - Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery Service at the Gregorio Maranón hospital. - Patients who voluntarily accept to participate in the study and sign the informed consent - Age> 18 years and legally capable - Scheduled surgery. - Functional respiratory tests with forced expiratory volume at one second > 50% or forced vital capacity > 50% preoperatively performed on these patients routinely. - Not having been on chronic treatment with oral corticosteroids or immunosuppressants three months before surgery. - Patients without previous history of liver disease. Exclusion Criteria: - Pregnancy and lactation - Known hypersensitivity to amide-type local anesthetics. - Transfusion of blood products in the previous 10 days. - Impossibility of performing mechanical ventilation for pulmonary protection. |
結果
主な結果の測定
1. Postoperative complications [up to 30 days after intervention]
二次的な結果の測定
1. gas exchange [24 hours]
2. Differences between three groups in Inflammatory biomarkers (IL 1, IL 2, IL 6, IL 8, IL 10, TNF alpha, MCP-1) measure in serum and bronchoalveolar lavage during 24 hours after the surgery. [up to 24 hours of intervention]
3. Analgesic requirements of opioids in the first 24 hours after the surgery [24 hours]
4. Special Care Units stay [up to 30 days after intervention]
5. Hospital stay [up to 30 days after intervention]
6. Re-admissions in Special Care Units [up to 30 days after intervention]
7. Postoperative cognitive dysfunction measure by mini mental state examination [up to 3 days after intervention]
8. Neuro-inflammatory response measure by the synthesis of protein S-100 beta in serum [up to 24 hours after intervention]
9. Neuro-inflammatory response measure by the synthesis of neuronal specific enolase in serum [up to 24 hours after intervention]
10. Neuro-inflammatory response measure by the synthesis of glial fibrillary acidic protein [up to 24 hours after intervention]
