Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents

Based on an international consensus conference held in Copenhagen in the autumn of 1994, a set of guidelines for Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents are presented. The guidelines are intended to be a help for people working in this research field, and it is hoped that the guidelines will assist researchers, editors, and drug companies to enhance the quality of their pharmacodynamic studies of neuromuscular blocking agents.     

Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision

The set of guidelines for good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents, which was developed following an international consensus conference in Copenhagen, has been revised and updated following the second consensus conference in Stockholm in 2005. It is hoped that these guidelines will continue to help researchers in the field and assist the pharmaceutical industry and equipment manufacturers in enhancing the standards of the studies they sponsor.     

Consensus guidelines for sustained neuromuscular blockade in critically ill children

BACKGROUND: The United Kingdom Paediatric Intensive Care Society Sedation, Analgesia and Neuromuscular Blockade Working Group is a multidisciplinary expert panel created to produce consensus guidelines on sedation, analgesia and neuromuscular blockade in critically ill children and forward knowledge in these areas. Neuromuscular blockade is recognized as an important element in the care of the critically ill and adult clinical practice guidelines in this area have been available for several years. However, similar clinical practice guidelines have not previously been produced for the critically ill pediatric patient. METHODS: A modified Delphi technique was employed to allow the Working Group to anonymously consider draft recommendations in up to three Delphi rounds with predetermined levels of agreement. This process was supported by a total of four consensus conferences and once consensus had been achieved, a systematic review of the available literature was carried out. RESULTS: A set of consensus guidelines was produced including six key recommendations. An evaluation of the existing literature supporting these recommendations is provided. CONCLUSIONS: Multidisciplinary consensus guidelines for maintenance neuromuscular blockade in critically ill children (excluding neonates) have been successfully produced and are supported by levels of evidence. The Working Group has highlighted the paucity of high quality evidence in these important clinical areas and this emphasizes the need for further randomized clinical trials in this area.     

Recommendations for standards of monitoring during anaesthesia and recovery 2021

This guideline updates and replaces the 5th edition of the Standards of Monitoring published in 2015. The aim of this document is to provide guidance on the minimum standards for monitoring of any patient undergoing anaesthesia or sedation under the care of an anaesthetist. The recommendations are primarily aimed at anaesthetists practising in the UK and Ireland, but it is recognised that these guidelines may also be of use in other areas of the world. Minimum standards for monitoring patients during anaesthesia and in the recovery phase are included. There is also guidance on monitoring patients undergoing sedation and during transfer. There are new sections specifically discussing capnography, sedation and regional anaesthesia. In addition, the indications for processed electroencephalogram and neuromuscular monitoring have been updated.     

Retraction: “Evaluation of residual neuromuscular blockade using modified double burst stimulation” by Saitoh Y,Nakazawa K,Makita K,Tanaka H and Toyooka H

The above article from Acta Anaesthesiologica Scandinavica, published on June 1997 in Wiley Online Library ( http://wileyonlinelibrary.com ) and in Volume 41, pp. 741-745, has been retracted by agreement between the authors, the journal Editor-in-Chief, Professor Michael Haney and John Wiley and Sons Ltd. The retraction has been agreed due to the lead author's declaration that official permission from the Ethical Committee of the Faculty of Medicine, Tokyo Medical and Dental University was not sought and therefore was not granted for this study. REFERENCE

1. Saitoh Y, Nakazawa K, Makita K, Tanaka H, Toyooka H. Evaluation of residual neuromuscular blockade using modified double burst stimulation. Acta Anaesthesiol Scand. 1997;41(6):741-745.

     

Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP)

In September 1997, an international consensus conference on standardization of studies of neuromuscular blocking agents was held in Copenhagen, Denmark. Based on the conference, a set of guidelines for good clinical research practice (GCRP) in pharmacokinetic studies of neuromuscular blocking agents is presented. Guidelines include: design of the study; relevant patient groups to investigate; test drug administration, sampling and analysis; pharmacokinetic analysis; pharmacokinetic/pharmacodynamic modeling; population pharmacokinetics; statistics; and presentation of pharmacokinetic data. The guidelines are intended to aid those working in this research area; it is hoped that they will assist researchers, editors of scientific papers, and pharmaceutical companies in improving the quality of pharmacokinetic studies.     

Infection or SIRS--the problem of definition]

Despite the knowledge about sepsis for many years, the definition of sepsis is contested more than ever since the early 90th. Therefore, the comparability of many clinical investigations and scientific work in the past is still impaired. To define the entrance criteria for further clinical studies, in 1991 a consensus conference was held in the USA, but its recommendations have not found unequivocal acceptance. Therefore, these recommendations are presented and their meaning will be discussed.     

Modified double burst stimulation at varying stimulating currents

The above article, published on August 1998 in Wiley Online Library ( http://wileyonlinelibrary.com ) and in Volume 42, pp. 851-857, has been retracted by agreement between the authors, the journal Editor-in-Chief, Professor Michael Haney and John Wiley and Sons Ltd. The retraction has been agreed due to the lead author's declaration that official permission from the Ethical Committee of the Faculty of Medicine, Tokyo Medical and Dental University was not sought and therefore was not granted for this study. REFERENCE

相似文献   

Retraction: “Modified double burst stimulation of varying stimulating currents” by Saitoh Y,Fujii Y,Makita K,Tanaka H and Amaha K

The above article, published on August 1998 in Wiley Online Library ( http://wileyonlinelibrary.com ) and in Volume 42, pp. 851-857, has been retracted by agreement between the authors, the journal Editor-in-Chief, Professor Michael Haney and John Wiley and Sons Ltd. The retraction has been agreed due to the lead author's declaration that official permission from the Ethical Committee of the Faculty of Medicine, Tokyo Medical and Dental University was not sought and therefore was not granted for this study. REFERENCE

1. Saitoh Y, Fujii Y, Makita K, Tanaka H, Amaha K. Modified double burst stimulation of varying stimulating currents. Acta Anaesthesiol Scand. 1998;42(7):851-857.

     

Monitoring techniques: neuromuscular blockade and depth of anaesthesia

Monitoring has always played a pivotal role in anaesthesia. It reduces the risks of incidents or accidents by giving us early warning signs prior to their occurrence. Neuromuscular and depth of anaesthesia monitoring, once considered advanced monitoring techniques are now essential elements of our anaesthetic practice. This article describes peripheral nerve stimulators and the importance of different patterns of stimulation to quantify the degree of neuromuscular blockade. The article will also focus on electroencephalogram analysis and stimulated evoked potentials for assessment of depth of anaesthesia. The physical principles of these methodologies and their role and limitations within the clinical context will be discussed including the current clinical guidance and recommendations for neuromuscular blockade and depth of anaesthesia assessment.     

Recommendations for reporting treatment of aortic graft infections

The purpose of these recommendations is to provide a standard format for reporting treatment results and standardised epidemiologic data after aortic vascular graft infection to improve the comparison of clinical outcomes between different therapeutic approaches and different study populations. Analytical reporting standards for patients' characteristics, type and extent of the disease, type of treatment and study design are described. Adherence to these recommendations will improve clinical relevance, quality and comparability of future studies dealing with aortic vascular graft infections.     

Standards for economic and quality of life studies in transplantation

There are unique requirements in conducting and reporting economic and quality of life investigations in medicine as compared with more traditional studies involving clinical outcomes. In addition, there are several unique characteristics of the discipline of transplantation that also bear attention in economic and quality of life studies. To provide guidelines for future research and reporting of future research, a consensus conference of transplant professionals was convened to discuss these issues. Five different areas were addressed: "Conducting an Economic Analysis," "Reporting an Economic Analysis," "Quality of Life Studies in Transplantation," "Ethical and Conflict of Interest Issues Between Sponsors and Investigators," and "Future Directions for Research." A series of recommendations for each of these areas with reference to relevant literature is presented.     

肌音描记法监测肌松作用的研究进展

肌松药已经广泛应用于临床麻醉及危重病人的呼吸支持治疗，对于肌松效果的监测就显得尤为重要。目前肌松作用监测的发展趋势有：①肌松监测仪向小型化发展，其结构趋于简单精巧、便于随身携带，价格减低，力求临床应用的普及，麻醉医生甚至可以人手一台；②肌松监测方法尽可能全面，监测的数据经由电脑处理，并与输液装置连接，可作闭环反馈控制自动给肌松药。理想的肌松监测应该是设备精巧、操作灵活方便、实用性强、精确度与灵敏性高，同时将其所致的不适感减轻到最少程度。肌音描记法符合肌松监测发展趋势，在临床具有潜在的应用远景，现将肌音描记法的研究进展作一综述。     

Residual neuromuscular blockade in the ICU: a prospective observational study and national survey

Residual neuromuscular blockade is associated with significant morbidity. It has been widely studied in anaesthesia; however, the incidence of residual neuromuscular blockade in patients managed in the ICU is unknown. We conducted a prospective observational study in a tertiary ICU to determine the incidence of residual neuromuscular blockade using quantitative accelerographic monitoring. We tested for residual neuromuscular blockade (defined as a train-of-four ratio < 0.9) before cessation of sedation in anticipation of tracheal extubation. We also surveyed 16 other ICUs in New Zealand to determine their use of neuromuscular monitoring. A total of 191 patients were included in the final analysis. The incidence (95%CI) of residual neuromuscular blockade was 43% (36–50%), with a similar incidence observed in non-postoperative and postoperative patients. There was a lower risk of residual neuromuscular blockade with atracurium than rocuronium (risk ratio (95%CI) of 0.39 (0.12–0.78)) and a higher risk with pancuronium than rocuronium (1.59 (1.06–2.49)). Our survey shows that, in New Zealand ICUs, monitoring of neuromuscular function is rarely carried out before tracheal extubation. When neuromuscular monitoring is undertaken, it is based on individual clinician suspicion and performed using qualitative measurements. No ICU reported using a quantitative monitor or a clinical guideline. The results demonstrate a high incidence of residual neuromuscular blockade in our ICU patients and identify the type of neuromuscular blocking drug as a possible risk factor. Monitoring neuromuscular function before tracheal extubation is not currently the standard of care in New Zealand ICUs. These data suggest that residual neuromuscular blockade may be an under-recognised problem in ICU practice.     

Monitoring techniques: neuromuscular blockade and depth of anaesthesia

Perioperative monitoring of both neuromuscular blockade and depth of anaesthesia has undergone considerable advancement and technological development in the past few decades. This article describes the role of the peripheral nerve stimulator and commonly used patterns of stimulation. It also discusses key technologies used to provide quantitative assessment of motor response. Techniques used to assess depth of anaesthesia are predominantly based on electroencephalogram analysis and stimulated evoked potentials. This article outlines the physical principles of these methodologies and discusses their role and limitations within the clinical context. Knowledge of advanced monitoring technologies available is essential to ensure correct use and avoid complications. Current clinical guidance and recommendations for neuromuscular blockade and depth of anaesthesia assessment are also discussed.     

Current evidence for the use of sugammadex in children

Sugammadex is a novel pharmacologic agent, which reverses neuromuscular blockade with a mechanism that differs from the commonly used, acetylcholinesterase inhibitors. Although sugammadex has not received approval from the United States Food & Drug administration in children, its use has already been reported to reverse neuromuscular blockade in several clinical scenarios in the pediatric population including the ‘cannot intubate–cannot ventilate’ scenario. To date, there remains limited data from prospective trials in the pediatric‐aged patient. Anecdotal use has been reported for the reversal of neuromuscular blockade in difficult clinical scenarios such as children with neuromuscular diseases including myasthenia gravis, Duchenne muscular dystrophy, and myotonic dystrophy.     

Can 4-Aminopyridine be Used to Reverse Anaesthesia and Muscle Relaxation?

4-aminopyridine has earlier been shown to antagonize neuromuscular block and to release transmitters in CNS. In a study in man the drug was given intravenously at the end of anaesthesia in order to counteract muscle relaxation and possibly also anaesthesia. The effects were followed by clinical observations, intraarterial blood pressure recording, ECG, repetitive muscle nerve stimulation and EEG. It was shown that the drug could reverse the neuromuscular block in lightly curarized patients, but was not as efficient as synstigmine methylsulphate (Neostigmine). In two cases the drug produced a slowing of EEG activity, which was normalized by naloxone. No toxic effects of the drug were observed.     

Laparoscopic antireflux surgery for gastroesophageal reflux disease (GERD)

Background: Laparoscopic antireflux surgery is currently a growing field in endoscopic surgery. The purpose of the Consensus Development Conference was to summarize the state of the art of laparoscopic antireflux operations in June 1996. Methods: Thirteen internationally known experts in gastroesophageal reflux disease were contacted by the conference organization team and asked to participate in a Consensus Development Conference. Selection of the experts was based on clinical expertise, academic activity, community influence, and geographical location. According to the criteria for technology assessment, the experts had to weigh the current evidence on the basis of published results in the literature. A preconsensus document was prepared and distributed by the conference organization team. During the E.A.E.S. conference, a consensus document was prepared in three phases: closed discussion in the expert group, public discussion during the conference, and final closed discussion by the experts. Results: Consensus statements were achieved on various aspects of gastroesophageal reflux disease and current laparoscopic treatment with respect to indication for operation, technical details of laparoscopic procedures, failure of operative treatment, and complete postoperative follow-up evaluation. The strength of evidence in favor of laparoscopic antireflux procedures was based mainly on type II studies. A majority of the experts (6/10) concluded in an overall assessment that laparoscopic antireflux procedures were better than open procedures. Conclusions: Further detailed studies in the future with careful outcome assessment are necessary to underline the consensus that laparoscopic antireflux operations can be recommended. Received: 29 November 1996/Accepted: 14 December 1996     

The Acute Dialysis Quality Initiative: the New York conference

Over 300,000 Americans develop acute renal failure each year, and half die. In recent years, there have been considerable advances in our understanding and technical capabilities, but consensus over the optimal way to deliver care does not exist. Consequently, a conference held in New York in the year 2000 has given birth to the Acute Dialysis Quality Initiative (ADQI). The conference aimed at establishing an evidence-based appraisal and set of consensus recommendations to standardize care and direct further research on the application of continuous renal replacement therapy (CRRT). CRRT is being used at ever-increasing rates in the United States. Today, approximately one quarter of all patients with acute renal failure are treated with CRRT. Despite the increasing use, there are presently no published standards for the application of this therapy, and practice patterns vary widely between individual centers. Results from recent clinical trials on selection of dialysis membranes and dialysis dose provide strong, yet often conflicting, evidence to guide therapy. Other areas of uncertainty have not been sufficiently addressed by clinical studies and directives for future research are needed. Finally, the success of multicentered clinical trials in supportive care in the intensive care unit (transfusion thresholds and ventilator management) have intensified and renewed interest in the study of supportive care methods as a major target for future research. These developments have set the stage for the first ADQI conference; the final objectives are the development of evidence-based practice guidelines and directions for future research.