A Phase 4 interventional study of Lidocaine and Remifentanil in Lung Diseases, Lung Inflammation and Lung Injury, Acute, sponsored by Francisco Andres de la Gala. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Francisco Andres de la Gala · Phase 4, Interventional, and Prevention
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. We design a randomized, controlled and blinded study to be performed in 153 patients with 3 arms: 1) Lidocaine IV + PV saline 2) saline IV + PV lidocaine, 3) remifentanil IV + PV saline. Perioperative analysis of inflammatory biomarkers in bronchoalveolar lavage and serum. Follow-up of the postoperative course, especially the appearance of postoperative complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical results.
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.
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This study's enrollment of 156 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
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Exclusion Criteria:
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.
Drug: Lidocaine
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.
Drug: 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: Remifentanil
Intravenous or paravertebral lidocaine
Also known as: Lignocaine, N-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide
intravenous remifentanil
Also known as: methyl 1-(2-methoxycarbonylethyl)-4-(phenyl-propanoyl-amino)-piperidine-4-carboxylate
Postoperative complications
to compare the proportion of patients included in the different scales of the Clavien-Dindo classification of postoperative complications reviewed for thoracic surgery in the three groups of patients. Patients will be followed from the day of hospital admission until hospital discharge and up to 30 days after the surgery
Time frame: up to 30 days after intervention
gas exchange
Compare the gas exchange (PaO2 / FiO2) at 24 hours after the intervention between the three groups of the study.
Time frame: 24 hours
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.
To evaluate the effect of intravenous lidocaine on the inflammatory response in lung resection surgery by measuring the inflammatory biomarkers (Interleukin(IL) 1, IL 2, IL 6, IL8, IL 10, tumor necrosis factor alfa and monocyte chemoattractant protein) in serum and in bronchoalveolar lavage, compared to the other two groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively. Bronchoalveolar lavage is done just before the beginning of one lung ventilation and at the end of one lung ventilation
Time frame: up to 24 hours of intervention
Analgesic requirements of opioids in the first 24 hours after the surgery
To compare the analgesic requirements of opioids in the immediate postoperative period (first 24 hours after the surgery) between the three groups of the study. When patients will be admitted in the postoperative care Unit a patient controlled analgesia pump of intravenous morphine 0,1% (bolus of 1mg) will be connected. The total dose of morphine self-administered by the patient in the first 24 hours after surgery will be recorded.
Time frame: 24 hours
Special Care Units stay
To compare the average stay (measure in hours) in Special Care Units among the three groups of the study
Time frame: up to 30 days after intervention
Hospital stay
To compare the average hospital stay (measure in days) among the three groups of the study
Time frame: up to 30 days after intervention
Re-admissions in Special Care Units
To compare the number of re-admissions in Special Care Units among the three groups of the study in the 30 days after the intervention.
Time frame: up to 30 days after intervention
Postoperative cognitive dysfunction measure by mini mental state examination
To analyze the incidence of postoperative cognitive dysfunction (POCD) in the three groups by comparing the mini mental state examination performed at admission and 3 days after the intervention.
Time frame: up to 3 days after intervention
Neuro-inflammatory response measure by the synthesis of protein S-100 beta in serum
To evaluated the neuro-inflammatory response by the synthesis of protein S-100 beta measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively
Time frame: up to 24 hours after intervention
Neuro-inflammatory response measure by the synthesis of neuronal specific enolase in serum
To evaluated the neuro-inflammatory response by the synthesis of neuronal specific enolase measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively
Time frame: up to 24 hours after intervention
Neuro-inflammatory response measure by the synthesis of glial fibrillary acidic protein
To evaluated the neuro-inflammatory response by the synthesis of glial fibrillary acidic protein measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively
Time frame: up to 24 hours after intervention
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Francisco Andres de la Gala