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Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery.

ABSTRACT: Cognitive decline after cardiac surgery remains common and diminishes patients' quality of life. Based on experimental and clinical evidence, this study assessed the potential of intravenously administered lidocaine to reduce postoperative cognitive dysfunction after cardiac surgery using cardiopulmonary bypass.After IRB approval, 277 patients undergoing cardiac surgery were enrolled into this prospective, randomized, double-blinded placebo controlled clinical trial. Subjects were randomized to receive: (1) Lidocaine as a 1 mg/kg bolus followed by a continuous infusion through 48 hours postoperatively, or (2) Placebo bolus and infusion. Cognitive function was assessed preoperatively and again at 6 weeks and 1 year postoperatively. The effect of lidocaine on postoperative cognition was tested using multivariable regression modeling; P<0.05 was considered significant.Among the 241 allocated subjects (Lidocaine: n=114; Placebo: n=127), the incidence of cognitive deficit in the lidocaine group was 45.5% versus 45.7% in the placebo group (P=0.97). Multivariable analysis revealed a significant interaction between treatment group and diabetes, such that diabetic subjects receiving lidocaine were more likely to suffer cognitive decline (P=0.004). Secondary analysis identified total lidocaine dose (mg/kg) as a significant predictor of cognitive decline and also revealed a protective effect of lower dose lidocaine in nondiabetic subjects.Lidocaine administered during and after cardiac surgery does not reduce the high rate of postoperative cognitive dysfunction. Higher doses of lidocaine and diabetic status were independent predictors of cognitive decline. Protective effects of lower dose lidocaine in nondiabetic subjects need to be further evaluated.

SUBMITTER: Mathew JP

PROVIDER: S-EPMC3718309 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

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Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery.

Mathew Joseph P JP Mackensen G Burkhard GB Phillips-Bute Barbara B Grocott Hilary P HP Glower Donald D DD Laskowitz Daniel T DT Blumenthal James A JA Newman Mark F MF

Stroke 20090122 3

<h4>Background and purpose</h4>Cognitive decline after cardiac surgery remains common and diminishes patients' quality of life. Based on experimental and clinical evidence, this study assessed the potential of intravenously administered lidocaine to reduce postoperative cognitive dysfunction after cardiac surgery using cardiopulmonary bypass.<h4>Methods</h4>After IRB approval, 277 patients undergoing cardiac surgery were enrolled into this prospective, randomized, double-blinded placebo controll ...[more]

PMID: 19164788

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Project description:BackgroundIntraoperative nerve monitoring (IONM) to assess the recurrent laryngeal nerve function during thyroid surgery is becoming the standard of care across many institutions. The successful deployment and data analysis from the IONM require complete laryngeal relaxation and reflex suppression. We investigated the role of intravenous lidocaine infusion (IVLI) to provide such operating conditions, under a lighter plane of anesthesia and fewer hemodynamic fluctuations.MethodsSixty-five patients were randomly assigned to lidocaine group (LG) or placebo group (PG) based on the computer-generated coding developed by the pharmacy department. The study medication (SM) was delivered by the pharmacist in a pre-filled coded syringe to the investigator 30 min prior to the surgery. All the patients were anesthetized by narcotic and inhalation based general anesthesia. The SM was administered at the rate of 1.5mg/kg/h following a loading dose of 1 mg/kg. Dragonfly® laryngeal surface electrode and Nerveana® nerve locator system were used for IONM during surgery.ResultsThe proportion of patients requiring lower strength stimulating current (StMC) at 0.5 mA was significantly higher in the LG than in the PG (X2 (1, N = 61) = 10.1615, P = 0.001434). Similarly, the proportion of patients with the drop in the aggregate impedance level (DAIL) by < 50% at the end of surgery was significantly higher in the LG than in the PG (X2 (1, N = 61) = 15.982, P = 0.000064). In addition, the proportion of patients with the hypotensive episodes requiring rescue medications more than twice during surgery was significantly lower in the LG than in the PG (X2 (1, N = 61) = 0.0183, P < 0.05).ConclusionsThe enhanced laryngeal relaxation and the reflex suppression afforded by the IVLI could have enabled a lower StMC to elicit a positive signal. The lower StMC promotes less intense laryngeal alterations as evidenced by the lower DAIL in the LG. IVLI can enhance the functionality of the IONM during prolonged operating time and the resultant increased number of IONM stimulations, while providing a stable hemodynamic environment.

Project description:BACKGROUND:The potential of neuroprotective agents should be revisited in the era of endovascular thrombectomy (EVT) for acute large-artery occlusion because their preclinical effects have been optimized for ischemia and reperfusion injury. Neu2000, a derivative of sulfasalazine, is a multi-target neuroprotectant. It selectively blocks N-methyl-D-aspartate receptors and scavenges for free radicals. This trial aimed to determine whether neuroprotectant administration before EVT is safe and leads to a more favorable outcome. METHODS:This trial is a phase-II, multicenter, three-arm, randomized, double-blinded, placebo-controlled, blinded-endpoint drug trial that enrolled participants aged ??19 years undergoing an EVT attempt less than 8 h from symptom onset, with baseline National Institutes of Health Stroke Scale (NIHSS) score???8, Alberta Stroke Program Early CT score???6, evidence of large-artery occlusion, and at least moderate collaterals on computed tomography angiography. EVT-attempted patients are randomized into control, low-dose (2.75 g), and high-dose (5.25 g) Neu2000KWL over 5 days. Seventy participants per group are enrolled for 90% power, assuming that the treatment group has a 28.4% higher proportion of participants with functional independence than the placebo group. The primary outcome, based on intention-to-treat criteria is the improvement of modified Rankin Scale (mRS) scores at 3 months using a dichotomized model. Safety outcomes include symptomatic intracranial hemorrhage within 5 days. Secondary outcomes are distributional change of mRS, mean differences in NIHSS score, proportion of NIHSS score 0-2, and Barthel Index >?90 at 1 and 4 weeks, and 3 months. DISCUSSION:The trial results may provide information on new therapeutic options as multi-target neuroprotection might mitigate reperfusion injury in patients with acute ischemic stroke before EVT. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02831088 . Registered on 13 July 2016.

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Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery.

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Randomized, double-blinded, placebo controlled study of neuroprotection with lidocaine in cardiac surgery.

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