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

被引:42
作者
Fuchs-Buder, Thomas [1 ]
Brull, Sorin J. [2 ]
Fagerlund, Malin Jonsson [3 ]
Renew, Ross J. [4 ]
Cammu, Guy [5 ]
Murphy, Glenn S. [6 ]
Warle, Michiel [7 ]
Vested, Matias [8 ]
Fulesdi, Bela [9 ]
Nemes, Reka [9 ]
Columb, Malachy O. [10 ]
Damian, Daniela [11 ]
Davis, Peter J. [12 ]
Iwasaki, Haijme [13 ]
Eriksson, Lars I. [3 ]
机构
[1] Univ Hosp Nancy, Dept Anaesthesia Crit Care & Perioperat Med, Nancy, France
[2] Mayo Clin, Coll Med & Sci, Jacksonville, FL USA
[3] Karolinska Univ Hosp, Perioperat Med & Intens Care, Stockholm, Sweden
[4] Mayo Clin, Dept Anesthesiol & Perioperat Med, Jacksonville, FL USA
[5] Dept Anesthesiol Crit Care & Emergency Med, Aalst, Belgium
[6] NorthShore Univ HealthSyst, Dept Anesthesiol, Chicago, IL USA
[7] Radbound Univ Med Ctr, Dept Surg, Nijmegen, Netherlands
[8] Univ Copenhagen, Dept Anesthesia, Rigshosp, Copenhagen, Denmark
[9] Univ Debrecen, Dept Anesthesiol & Intens Care, Debrecen, Hungary
[10] Manchester Univ Hosp NHS Fdn Trust, Anaesthesia & Intens Med, Manchester, England
[11] UPMC Childrens Hosp, Anesthesiol & Perioperat Med, Pittsburgh, PA USA
[12] UPMC Childrens Hosp, Anesthesia & Pediat, Pittsburgh, PA USA
[13] Asahikawa Med Univ, Dept Anesthesiol & Crt Care Med, Asahikawa, Japan
关键词
depth of neuromuscular blockade; neuromuscular monitoring; neuromuscular research; pharmacodynamics; postoperative pulmonary complications; time course of neuromuscular blockade; ACQUIRED MUSCLE WEAKNESS; POLLICIS TWITCH TENSION; DOSE-RESPONSE CURVE; 2 DIFFERENT MODES; TRAIN-OF-4; STIMULATION; STAIRCASE PHENOMENON; TRACHEAL INTUBATION; STIMULUS FREQUENCY; NERVE-STIMULATION; TOF-GUARD;
D O I
10.1111/aas.14279
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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.
引用
收藏
页码:994 / 1017
页数:24
相关论文
共 109 条
[1]   A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications [J].
Abbott, T. E. F. ;
Fowler, A. J. ;
Pelosi, P. ;
de Abreu, M. Gama ;
Moller, A. M. ;
Canet, J. ;
Creagh-Brown, B. ;
Mythen, M. ;
Gin, T. ;
Lalu, M. M. ;
Futier, E. ;
Grocott, M. P. ;
Schultz, M. J. ;
Pearse, R. M. .
BRITISH JOURNAL OF ANAESTHESIA, 2018, 120 (05) :1066-1079
[2]   STIMULUS FREQUENCY AND DOSE-RESPONSE CURVE TO D-TUBOCURARINE IN MAN [J].
ALI, HH ;
SAVARESE, JJ .
ANESTHESIOLOGY, 1980, 52 (01) :36-39
[3]   STIMULUS FREQUENCY IN DETECTION OF NEUROMUSCULAR BLOCK IN HUMANS [J].
ALI, HH ;
UTTING, JE ;
GRAY, C .
BRITISH JOURNAL OF ANAESTHESIA, 1970, 42 (11) :967-+
[4]  
Ambesh Sushil Prakash, 2013, Acta Anaesthesiol Taiwan, V51, P58, DOI 10.1016/j.aat.2013.06.005
[5]  
[Anonymous], 1990, Pharmacol Toxicol, V67, P361
[6]  
[Anonymous], 2008, Ethical principles for medical research involving human subjects
[7]  
[Anonymous], 2008, Curr Anaesth Crit Care, DOI [10.1016/j.cacc.2008.07.001, DOI 10.1016/J.CACC.2008.07.001]
[8]   STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT [J].
BLAND, JM ;
ALTMAN, DG .
LANCET, 1986, 1 (8476) :307-310
[9]   Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease [J].
Bourgeois, Florence T. ;
Orenstein, Liat ;
Ballakur, Sarita ;
Mandl, Kenneth D. ;
Ioannidis, John P. A. .
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 2017, 65 (11) :2354-2361
[10]   A comparison of a prototype electromyograph vs. a mechanomyograph and an acceleromyograph for assessment of neuromuscular blockade [J].
Bowdle, A. ;
Bussey, L. ;
Michaelsen, K. ;
Jelacic, S. ;
Nair, B. ;
Togashi, K. ;
Hulvershorn, J. .
ANAESTHESIA, 2020, 75 (02) :187-195