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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:Background Multimodal analgesia that provides optimal pain treatment with minimal side effects is important for optimal recovery after open cardiac surgery. Regional anaesthesia can be used to block noxious nerve signals. Because sternotomy causes considerable pain that lasts several days, a continuous nerve block is advantageous. Previous studies on continuous sternal wound infusion or parasternal blocks with long-acting local anaesthetics have shown mixed results. This study aims to determine whether a continuous bilateral parasternal block with lidocaine, which is a short-acting local anaesthetic that has a favourable safety/toxicity profile, results in effective analgesia. We hypothesise that a 72-hour continuous parasternal block with 0.5% lidocaine at a rate of 7 ml/hour on each side provides effective analgesia and reduces opioid requirement. We will evaluate whether recovery is enhanced. Methods In a prospective, randomised, double-blinded manner, 45 patients will receive a continuous parasternal block with either 0.5% lidocaine or saline. The primary endpoint is cumulated intravenous morphine by patient-controlled analgesia at 72 hours. Secondary end-points include the following: (1) the cumulated numerical rating scale (NRS) score recorded three times daily at 72 hours; (2) the cumulated NRS score after two deep breaths three times daily at 72 hours; (3) the NRS score at rest and after two deep breaths at 2, 4, 8 and 12 weeks after surgery; (4) oxycodone requirement at 2, 4, 8 and 12 weeks after surgery; (5) Quality of Recovery-15 score preoperatively compared with that at 24, 48 and 72 hours, and at 2, 4, 8 and 12 weeks after surgery; (6) preoperative peak expiratory flow compared with postoperative daily values for 3 days; and (7) serum concentrations of interleukin-6 and lidocaine at 1, 24, 48 and 72 hours postoperatively compared with preoperative values. Discussion Adequate analgesia is important for quality of care and vital to a rapid recovery after cardiac surgery. This study aims to determine whether a continuous parasternal block with a short-acting local anaesthetic improves analgesia and recovery after open cardiac procedures. Trial registration The study was registered in the European Clinical Trials Database on 27/9/2019 (registration number: 2018-004672-35). Supplementary Information The online version contains supplementary material available at 10.1186/s13063-022-06469-5.

Project description:BackgroundDespite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a "real-world" trial in cardiac surgery.ObjectiveWe sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient.DesignA pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy.SettingA large tertiary academic center in London Ontario between September 2009 and February 2011.ParticipantsPatients undergoing planned, isolated coronary revascularization.MeasurementsSerum creatinine and patient weight were measured daily postoperatively.MethodsPatients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization.ResultsThe study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, "risk" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas "injury" occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups.LimitationsThe study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes.ConclusionsThis pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

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.

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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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