Articles: anesthetics.
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Multicenter Study Comparative Study Observational Study
Determination of loss of consciousness: a comparison of clinical assessment, bispectral index and electroencephalogram: An observational study.
Computer-processed algorithms of encephalographic signals are widely used to assess the depth of anaesthesia. However, data indicate that the bispectral index (BIS), a processed electroencephalography monitoring system, may not be reliable for assessing the depth of anaesthesia. ⋯ This trial was not registered because registration was not mandatory at the time of the trial.
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Multicenter Study Pragmatic Clinical Trial
Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial.
Hip fractures occur 1.6 million times each year worldwide, with substantial associated mortality and losses of independence. At present, anaesthesia care for hip fracture surgery varies widely within and between countries, with general anaesthesia and spinal anaesthesia representing the 2 most common approaches. Limited randomised evidence exists regarding potential short-term or long-term differences in outcomes between patients receiving spinal or general anaesthesia for hip fracture surgery. ⋯ The REGAIN trial has been approved by the ethics boards of all participating sites. Recruitment began in February 2016 and will continue until the end of 2019. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets.
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Randomized Controlled Trial Multicenter Study
A Randomized, Multicenter, Double-Blind Study of Local Infiltration Analgesia with Liposomal Bupivacaine for Postsurgical Pain Following Total Knee Arthroplasty: Rationale and Design of the Pillar Trial.
Liposomal bupivacaine, a prolonged-release formulation of bupivacaine hydrochloride, is indicated for infiltration into the surgical site for postsurgical analgesia. Results from previous total knee arthroplasty (TKA) studies suggest that analgesic efficacy associated with liposomal bupivacaine may be impacted by variability in infiltration technique. The PILLAR study is designed to assess liposomal bupivacaine efficacy in TKA using a standardized infiltration protocol. Materials and Methods/Design: This phase 4, multicenter, randomized, double-blind, controlled, parallel-group study will compare the safety and efficacy of infiltration with liposomal bupivacaine versus standard bupivacaine for postsurgical pain control in adults undergoing primary unilateral TKA. All subjects will receive a standardized pre-surgical analgesic regimen, and will be randomized to receive either liposomal bupivacaine 266 mg/20 mL (admixed with standard bupivacaine 0.5% 20 mL and expanded to a total volume of 120 mL) or bupivacaine 0.5% 20 mL (expanded to a total volume of 120 mL). The study drug will be infiltrated using six syringes (prefilled with 20 mL of study drug solution) to deliver 1-1.5 mL infusions into prespecified periarticular tissues. All subjects will receive standardized postsurgical analgesia and access to rescue medication. The co-primary efficacy endpoints are area under the curve of visual analog scale pain intensity scores from 12-48 hours postsurgery and total postsurgical opioid consumption from 0-48 hours. Secondary efficacy endpoints include other pain assessments, time to first use of rescue medication, discharge readiness, use of skilled nursing facilities, and hospital length of stay. Safety will be evaluated based on adverse events. ⋯ The use of a standardized protocol comparing infiltration of equal volumes of the study drug, designed by experienced investigators to ensure complete coverage of all areas innervating the surgical site while minimizing leakage of study drug, will help define the role of liposomal bupivacaine in the setting of TKA.
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Pediatr Crit Care Me · Oct 2016
Multicenter Study Observational StudyRefractory Status Epilepticus in Children: Intention to Treat With Continuous Infusions of Midazolam and Pentobarbital.
To describe pediatric patients with convulsive refractory status epilepticus in whom there is intention to use an IV anesthetic for seizure control. ⋯ Midazolam and pentobarbital remain the mainstay of continuous infusion therapy for refractory status epilepticus in the pediatric patient. The majority of patients experience seizure termination within a median of 30 hours. These data have implications for the design and feasibility of future intervention trials. That is, testing a new anesthetic anticonvulsant after failure of both midazolam and pentobarbital is unlikely to be feasible in a pediatric study, whereas a decision to test an alternative to pentobarbital, after midazolam failure, may be possible in a multicenter multinational study.
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Lancet Gastroenterol Hepatol · Oct 2016
Randomized Controlled Trial Multicenter StudyContinuous wound infiltration versus epidural analgesia after hepato-pancreato-biliary surgery (POP-UP): a randomised controlled, open-label, non-inferiority trial.
Epidural analgesia is the international standard for pain treatment in abdominal surgery. Although some studies have advocated continuous wound infiltration with local anaesthetics, robust evidence is lacking, especially on patient-reported outcome measures. We aimed to determine the effectiveness of continuous wound infiltration in hepato-pancreato-biliary surgery. ⋯ Academic Medical Centre, Amsterdam, Netherlands.