Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial

被引:1
作者
Ni, Wenwen [1 ]
Yi, Xiuwen [1 ]
Feng, Lili [1 ]
Shen, Yilei [1 ]
Jiao, Jiali [2 ]
Cai, Yirong [1 ]
Fu, Danyun [1 ]
Han, Yuan [1 ]
Jia, Ji'e [1 ]
Li, Wenxian [1 ]
机构
[1] Fudan Univ, Eye & ENT Hosp, Dept Anesthesiol, 83 Fenyang Rd, Shanghai 200031, Peoples R China
[2] Shanghai Jiao Tong Univ, Inst Translat Med, 800 Dongchuan Rd, Shanghai, Peoples R China
关键词
Obese; Remimazolam tosylate; Induction dose; Lean body weight; Randomized controlled trial; BODY-WEIGHT; CNS; 7056; PROPOFOL;
D O I
10.1186/s13063-023-07739-6
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background The physiologic and anthropometric characteristics changes associated with obesity may result in the alternation of pharmacologic management. Remimazolam tosylate is a new type of ultra-short-acting benzodiazepine with stable context-sensitive half-time (CSHT) and no lipid accumulation after long-time infusion. Although remimazolam tosylate has potential advantages for the induction and maintenance of anesthesia in obese patients, the appropriate induction dosing scalars among obese patients are unknown. Therefore, we aim to compare the different weight-based scalars for dosing remimazolam tosylate of anesthesia induction among obese patients.Methods/design The study will be performed as a prospective, single-center, double-blind, controlled clinical trial. The study design is a comparison of remimazolam tosylate requirements based on total body weight (TBW) or lean body weight (LBW) to reach a Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score of 0 among obese subjects (BMI >= 35 kg/m(2)). Another twenty normal-weight subjects (18.5 kg/m(2) <= BMI < 25 kg/m(2)) will be enrolled as a control group, whose induction dose is scaled based on TBW. The infusion rate of remimazolam tosylate during induction is 12 mg/kg/h in all groups.Discussion Results of the present study will provide evidence of dose scalar of remimazolam tosylate to guide the clinical practice of anesthesia induction in obese patients.
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共 30 条
[1]   Health Effects of Overweight and Obesity in 195 Countries over 25 Years [J].
Afshin, Ashkan ;
Forouzanfar, Mohammad H. ;
Reitsma, Marissa B. ;
Sur, Patrick ;
Estep, Kara ;
Lee, Alex ;
Marczak, Laurie ;
Mokdad, Ali H. ;
Moradi-Lakeh, Maziar ;
Naghavi, Mohsen ;
Salama, Joseph S. ;
Vos, Theo ;
Abate, Kalkidan H. ;
Abbafati, Cristiana ;
Ahmed, Muktar B. ;
Al-Aly, Ziyad ;
Alkerwi, Ala'a ;
Al-Raddadi, Rajaa ;
Amare, Azmeraw T. ;
Amberbir, Alemayehu ;
Amegah, Adeladza K. ;
Amini, Erfan ;
Amrock, Stephen M. ;
Anjana, Ranjit M. ;
Arnlov, Johan ;
Asayesh, Hamid ;
Banerjee, Amitava ;
Barac, Aleksandra ;
Baye, Estifanos ;
Bennett, Derrick A. ;
Beyene, Addisu S. ;
Biadgilign, Sibhatu ;
Biryukov, Stan ;
Bjertness, Espen ;
Boneya, Dube J. ;
Campos-Nonato, Ismael ;
Carrero, Juan J. ;
Cecilio, Pedro ;
Cercy, Kelly ;
Ciobanu, Liliana G. ;
Cornaby, Leslie ;
Damtew, Solomon A. ;
Dandona, Lalit ;
Dandona, Rakhi ;
Dharmaratne, Samath D. ;
Duncan, Bruce B. ;
Eshrati, Babak ;
Esteghamati, Alireza ;
Feigin, Valery L. ;
Fernandes, Joao C. .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (01) :13-27
[2]   Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation [J].
Baraka, A. S. ;
Taha, S. K. ;
Siddik-Sayyid, S. M. ;
Kanazi, G. E. ;
El-Khatib, M. F. ;
Dagher, C. M. ;
Chehade, J.-M. A. ;
Abdallah, F. W. ;
Hajj, R. E. .
ANAESTHESIA, 2007, 62 (08) :769-773
[3]   On the Accuracy of Estimation of Basic Pharmacokinetic Parameters by the Traditional Noncompartmental Equations and the Prediction of the Steady-State Volume of Distribution in Obese Patients Based Upon Data Derived from Normal Subjects [J].
Berezhkovskiy, Leonid M. .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2011, 100 (06) :2482-2497
[4]   The Role of GABA Receptor Agonists in Anesthesia and Sedation [J].
Brohan, Janette ;
Goudra, Basavana G. .
CNS DRUGS, 2017, 31 (10) :845-856
[5]   SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials [J].
Chan, An-Wen ;
Tetzlaff, Jennifer M. ;
Gotzsche, Peter C. ;
Altman, Douglas G. ;
Mann, Howard ;
Berlin, Jesse A. ;
Dickersin, Kay ;
Hrobjartsson, Asbjorn ;
Schulz, Kenneth F. ;
Parulekar, Wendy R. ;
Krleza-Jeric, Karmela ;
Laupacis, Andreas ;
Moher, David .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 346
[6]  
CHERNIK DA, 1990, J CLIN PSYCHOPHARM, V10, P244
[7]   Relations of stroke volume and cardiac output to body composition - The strong heart study [J].
Collis, T ;
Devereux, RB ;
Roman, MJ ;
de Simone, G ;
Yeh, JL ;
Howard, BV ;
Fabsitz, RR ;
Welty, TK .
CIRCULATION, 2001, 103 (06) :820-825
[8]   Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial [J].
Doi, Matsuyuki ;
Morita, Kiyoshi ;
Takeda, Junzo ;
Sakamoto, Atsuhiro ;
Yamakage, Michiaki ;
Suzuki, Toshiyasu .
JOURNAL OF ANESTHESIA, 2020, 34 (04) :543-553
[9]   Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in high-risk surgical patients (ASA Class III): results of a multicenter, randomized, double-blind, parallel-group comparative trial [J].
Doi, Matsuyuki ;
Hirata, Naoyuki ;
Suzuki, Toshiyasu ;
Morisaki, Hiroshi ;
Morimatsu, Hiroshi ;
Sakamoto, Atsuhiro .
JOURNAL OF ANESTHESIA, 2020, 34 (04) :491-501
[10]   What is the best size descriptor to use for pharmacokinetic studies in the obese? [J].
Green, B ;
Duffull, SB .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2004, 58 (02) :119-133