Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision

The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby-Mogensen et al., Acta Anaesthesiol Scand 1996, 40 , 59–74); the guidelines were later revised and updated following the second consensus conference in Stockholm in 2005 (Fuchs-Buder et al., Acta Anaesthesiol Scand 2007, 51 , 789–808). In view of new devices and further development of monitoring technologies that emerged since then, (e.g., electromyography, three-dimensional acceleromyography, kinemyography) as well as novel compounds (e.g., sugammadex) a review and update of these recommendations became necessary. The intent of these revised guidelines is to continue to help clinical researchers to conduct high-quality work and advance the field by enhancing the standards, consistency, and comparability of clinical studies. There is growing awareness of the importance of consensus-based reporting standards in clinical trials and observational studies. Such global initiatives are necessary in order to minimize heterogeneous and inadequate data reporting and to improve clarity and comparability between different studies and study cohorts. Variations in definitions of endpoints or outcome variables can introduce confusion and difficulties in interpretation of data, but more importantly, it may preclude building of an adequate body of evidence to achieve reliable conclusions and recommendations. Clinical research in neuromuscular pharmacology and physiology is no exception.     

青年人群近距离工作后眼部参数的变化及恢复时间

目的：观察青年人群近距离用眼后眼部生理及功能性参数的变化及恢复时间。

方法：前瞻性研究。随机选取2019-12/2020-06在我院进行医学验光的患者69例138眼，根据主觉验光结果分为正视组(+0.75D≤等效球镜度≤-0.50D，18例36眼)、低度近视组(-0.75D≤等效球镜度≤-3.00D，25例50眼)和中度近视组(-3.25D≤等效球镜度≤-6.00D，26例52眼)。所有受试者近距离阅读20min后远眺放松20min，分别于近距离用眼前、近距离用眼20min后、远眺5、10、15、20min时测量受试者眼部生理性参数\〖前房深度(ACD)、眼轴长度(AL)\〗和功能性参数\〖正相对调节(PRA)、调节反应(BCC)\〗，分析各参数的达极时间和恢复时间。

结果：近距离用眼后眼轴变长，前房变浅，PRA绝对值变大，BCC无明显变化，75%(52/69)的受试者AL在近距离用眼20min后达极，87%(60/69)的受试者ACD在远眺5min时达极，96%(66/69)的受试者PRA在近距离用眼20min后达极，且以上参数均在远眺10min后逐渐恢复至初始状态。

结论：近距离用眼后眼部参数发生改变，眼轴变长，前房变浅，PRA绝对值增大，但均在远眺放松过程中逐渐回退，且均需要10min以上才能恢复至初始状态。     

圆锥型套筒冠修复体修复治疗对牙周病患者牙龈指数、龈乳头探诊出血指数、牙周探诊深度的影响

目的 探讨圆锥型套筒冠修复体修复治疗对牙周病患者牙龈指数、龈乳头探诊出血指数、牙周探诊深度的影响。方法 选取2017年3月～2019年3月我院收治的牙周病患者60例,随机分为对照组和研究组两组。对照组进行常规治疗,研究组进行圆锥型套筒冠修复体修复治疗。比较两组患者疗效、牙齿松动度(TM)、牙龈指数(GI)、龈乳头探诊出血指数(PBI)、牙周探诊深度(PD)、改良菌斑指数(mPLI)、改良龈沟出血指数(MSBI)、牙龈乳头指数(PIS)、白细胞介素-8(IL-8)、白细胞介素-2(IL-2)水平、口腔健康影响程度评分(OHIP-14)、咀嚼功能、满意率。结果 研究组有效率高于对照组(P0.05);研究组TM、GI、PBI、PD低于对照组(P0.05);研究组mPLI、MSBI、PIS低于对照组(P0.05);研究组IL-8、IL-2水平低于对照组(P0.05);研究组OHIP-14评分低于对照组(P0.05);研究组咀嚼功能高于对照组(P0.05);研究组修复满意率高于对照组(P0.05)。结论 牙周病治疗中,圆锥型套筒冠修复体修复疗效显著,应在临床上广泛推广与应用。     

Impact of Dentin Substrate Modification with Chitosan-Hydroxyapatite Precursor Nanocomplexes on Sealer Penetration and Tensile Strength

IntroductionThe purpose of this study was to evaluate the effect of dentin conditioning with chitosan-hydroxyapatite precursor (C-HA) nanocomplexes on the depth of tricalcium silicate sealer penetration into dentinal tubules and ultimate tensile strength (UTS).Methodssurface charge and size distribution for C-HA nanocomplex formulation was evaluated followed by bioactivity assessment of standardized films of C-HA nanocomplexes (n = 15) incubated in simulated body fluid. Mineralization potential was assessed with X-ray diffraction and Fourier-transform infrared spectroscopy, whereas scanning electron microscopy was used for ultrastructural evaluation. Static water contact angles and UTS were measured on dentin discs (n = 2/group) and dentin beams (n = 10/group) treated with/without sodium hypochlorite/EDTA and C-HA nanocomplex conditioning. In phase 2, the depth of sealer penetration after C-HA nanocomplex conditioning was evaluated using fluorescent imaging (n = 12/group). The percent area penetration and mean/maximum penetration depth were calculated at 4- and 6-mm levels from the root apex. Data from contact angle measurements, mechanical testing, and penetration assessment parameters were subjected to the independent samples t test with a significance level set at P < .05.ResultsA formulation of C-HA nanocomplexes (2 mg/mL) was chosen as a polyanionic, hydrophilic, nonaggregating concentration having bioactivity potential established through the formation of phosphate/carbonate bonds and the crystalline nature of the formed minerals. A significantly lower contact angle and higher UTS were registered for the C-HA nanocomplex–conditioned group (P < .05). Statistically significant (P < .05) greater sealer penetration was recorded at the 4-mm level for all assessment parameters and percent area penetration at 6 mm for the C-HA nanocomplex group.ConclusionsC-HA nanocomplex conditioning enhances dentin surface wettability to facilitate greater tricalcium silicate sealer penetration and UTS of dentin.     

La técnica de superposición de cúspides en TAVI con dispositivo autoexpandible optimiza la profundidad del implante y reduce la necesidad de marcapasos permanente

Introduction and objectivesThis study aimed to determine the safety and efficacy of modifying the classic implantation technique for aortic transcatheter heart valve (THV) implantation to a cusp-overlap-projection (COP) technique to achieve a higher implantation depth and to reduce the burden of new permanent pacemaker implantation (PPMI) at 30 days. Aortic self-expanding THV carries an elevated risk for PPMI. A higher implantation depth minimizes the damage in the conduction system and may reduce PPMI rates.MethodsFrom March 2017, 226 patients were consecutively included: 113 patients were treated using the COP implantation technique compared with the previous 113 consecutive patients treated using the classic technique. In all patients, implantation depth was assessed by 3 methods (noncoronary cusp to the THV, mean of the noncoronary cusp and the left coronary cusp to the THV, and the deepest edge from the left coronary cusp and the noncoronary cusp to the THV).ResultsThe COP group had a lower implantation depth than the group treated with the classic technique (4.8 mm ± 2.2 vs 5.7 mm ± 3.1; P = .011; 5.8 mm ± 3.1 vs 6.5 mm ± 2.4; P = .095; 7.1 mm ± 2.8 vs 7.4 mm ± 3.2; P = .392). Forty patients (17.7%) required a new PPMI after the 30-day follow-up but this requirement was significantly lower in the COP group (12.4% vs 23%, P = .036). The COP implantation technique consistently protected against the main event (OR, 0.45; 95%CI, 0.21-0.97; P = .043), with similar procedural success rates and complications.ConclusionsThe COP implantation technique is a simple modification of the implantation protocol and provides a higher implantation depth of self-expanding-THV with lower conduction disturbances and PPMI rates.     

Changes in electroencephalographic power and bicoherence spectra according to depth of dexmedetomidine sedation in patients undergoing spinal anesthesia

Background: Assessment the depth of dexmedetomidine sedation using electroencephalographic (EEG) features can improve the quality of procedural sedation. Previous volunteer studies of dexmedetomidine-induced EEG changes need to be validated, and changes in bicoherence spectra during dexmedetomidine sedation has not been revealed yet. We aimed to investigate the dexmedetomidine-induced EEG change using power spectral and bicoherence analyses in the clinical setting.Patients and Methods: Thirty-six patients undergoing orthopedic surgery under spinal anesthesia were enrolled in this study. Dexmedetomidine sedation was conducted by the stepwise increase in target effect site concentration (Ce) while assessing sedation levels. Bispectral index (BIS) and frontal electroencephalography were recorded continuously, and the performance of BIS and changes in power and bicoherence spectra were analyzed with the data from the F3 electrode.Results: The prediction probability values for detecting different sedation levels were 0.847, 0.841, and 0.844 in BIS, 95% spectral edge frequency, and dexmedetomidine Ce, respectively. As the depth of sedation increased, δ power increased, but high β and γ power decreased significantly (P <0.001). α and spindle power increased significantly under light and moderate sedation (P <0.001 in light vs baseline and deep sedation; P = 0.002 and P <0.001 in moderate sedation vs baseline and deep sedation, respectively). The bicoherence peaks of the δ and α-spindle regions along the diagonal line of the bicoherence matrix emerged during moderate and deep sedation. Peak bicoherence in the δ area showed sedation-dependent increases (29.93%±7.38%, 36.72%±9.70%, 44.88%±12.90%; light, moderate, and deep sedation; P = 0.008 and P <0.001 in light sedation vs moderate and deep sedation, respectively; P = 0.007 in moderate sedation vs deep sedation), whereas peak bicoherence in the α-spindle area did not change (22.92%±4.90%, 24.72%±4.96%, and 26.96%±8.42%, respectively; P=0.053).Conclusions: The increase of δ power and the decrease of high-frequency power were associated with the gradual deepening of dexmedetomidine sedation. The δ bicoherence peak increased with increasing sedation level and can serve as an indicator reflecting dexmedetomidine sedation levels.