Feature Reports:day surgery anesthesia

A randomized controlled study of remimazolam tosilate under bispectral index and bypass EtCO2 monitoring in daytime hysteroscopic surgery

  • Junjie ZHANG ,
  • Xiaochun YANG ,
  • Zhuoyi LIU ,
  • Ruoqiu WU ,
  • Ping LI ,
  • Qulian GUO ,
  • E. WANG
Expand
  • *.Department of Anesthesiology,Xiangya Hospital,Central South University,Changsha 410008,China
    *.National Clinical Research Center for Geriatric Disorders,Changsha 410008,China

Received date: 2023-11-13

  Online published: 2024-04-19

Abstract

Objective To study the efficacy and safety of remimazolam tosilate in painless daytime hysteroscopic surgery. Methods A total of 300 patients (18 ~ 60 years, BMI 18.5 ~ 27 kg/m2, and ASA Ⅰ-Ⅱ) undergoing selected painless daytime hysteroscopic surgery were randomized into two groups. Group R received remimazolam tosilate at an initial dose of 0.2 mg/kg, and then single 0.05 mg/kg if needed according to bispectral index. Group P, according to the bispectral index, received propofol at an initial dose of 1.5 ~ 2 mg/kg, and single 0.5 mg/kg if needed. All the patients were intravenously given 5 μg sufentanil five minutes before hysteroscopy. The anesthesia-related indicators (anesthesia onset time, surgical duration, anesthesia recovery time, and time to leaving the operating room) and safety indexes (hypotension, hypoxia, nausea and vomiting, and doctor and patient satisfaction) were recorded. Results The incidence of hypotension and injection pain was significantly higher in group P (P < 0.01). There were no significant differences between the two groups in surgical duration, awakening time, time to leaving the operating room, nausea and vomiting, and patient satisfaction (P > 0.05). Conclusion Remimazolam can be used safely and effectively in painless daytime hysteroscopic surgery.

Cite this article

Junjie ZHANG , Xiaochun YANG , Zhuoyi LIU , Ruoqiu WU , Ping LI , Qulian GUO , E. WANG . A randomized controlled study of remimazolam tosilate under bispectral index and bypass EtCO2 monitoring in daytime hysteroscopic surgery[J]. The Journal of Practical Medicine, 2024 , 40(8) : 1047 -1051 . DOI: 10.3969/j.issn.1006-5725.2024.08.004

References

1 殷倩, 孙时清, 吴晓凤,等. 宫腹腔镜联合手术与腹腔镜手术治疗Ⅲ型剖宫产瘢痕妊娠的效果及围术期应激反应分析[J].中国性科学, 2022,31(1):113-116. doi:10.3969/j.issn.1672-1993.2022.01.028
2 邹群飞, 朱坤仪, 梁红玲. 丙泊酚分别伍用芬太尼及舒芬太尼用于无痛宫腔镜检查的比较[J]. 中国妇幼保健, 2013, 028(3):539-540. doi:10.7620/zgfybj.j.issn.1001-4411.2013.03.57
3 DINIS-OLIVEIRA R J. Metabolic Profiles of Propofol and Fospropofol: Clinical and Forensic Interpretative Aspects[J]. Biomed Res Int, 2018, 2018: 6852857. doi:10.1155/2018/6852857
4 ZAKI H A, SHALLIK N, SHABAN E, et al. An Analytical Comparison Between Ketamine Alone and a Combination of Ketamine and Propofol (Ketofol) for Procedural Sedation and Analgesia From an Emergency Perspective: A Systematic Review and Meta-Analysis[J]. Cureus,2022,14(7):e27318.
5 KIM K M. Remimazolam: pharmacological characteristics and clinical applications in anesthesiology[J]. Anesth Pain Med (Seoul), 2022,17(1):1-11. doi:10.17085/apm.21115
6 SHENG X Y, LIANG Y, YANG X Y, et al. Safety, pharmacokinetic and pharmacodynamic properties of single ascending dose and continuous infusion of remimazolam besylate in healthy Chinese volunteers[J]. Eur J Clin Pharmacol, 2020,76(3):383-391. doi:10.1007/s00228-019-02800-3
7 WILTSHIRE H R, KILPATRICK G J, TILBROOK G S, et al. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam(CNS 7056): Part II. Population pharmacokinetic and pharmacodynamic modeling and simulation[J]. Anesth Analg, 2012, 115(2): 284-296. doi:10.1213/ane.0b013e318241f68a
8 BORKETT K M, RIFF D S, SCHWARTZ H I,et al. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy[J]. Anesth Analg, 2015, 120(4): 771-780. doi:10.1213/ane.0000000000000548
9 YAMADA J, HAZAMA D, TACHIHARA M, et al. The utility of bispectralindex monitoring in flexible bronchoscopy: A single-center, retrospective observational study[J]. Thorac Cancer,2022,13(21):3052-3057. doi:10.1111/1759-7714.14658
10 ROCHE D, MAHON P. Depth of Anesthesia Monitoring [J]. Anesthesiol Clin, 2021,39(3):477-492. doi:10.1016/j.anclin.2021.04.004
11 RüSCH D, ARNDT C, EBERHART L,et al. Bispectral index to guide induction of anesthesia: a randomized controlled study[J]. BMC Anesthesiol, 2018,18(1): 66. doi:10.1186/s12871-018-0522-8
12 BARNETT S, HUNG A, TSAO R,et al. Capnographic Monitoring of Moderate Sedation During Low-Risk Screening Colonoscopy Does Not Improve Safety or Patient Satisfaction: A Prospective Cohort Study[J]. Am J Gastroenterol, 2016, 111(3): 388-394. doi:10.1038/ajg.2016.2
13 ZHOU Y Y, YANG S T, DUAN K M, et al. Efficacy and safety of remimazolam besylate in bronchoscopy for adults: A multicenter, randomized, double-blind, positive-controlled clinical study [J]. Front Pharmacol, 2022,13:1005367. doi:10.3410/f.742389523.793597171
14 REX D K, BHANDARI R, LORCH D G,et al. Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial[J]. Dig Liver Dis, 2021, 53(1): 94-101. doi:10.1016/j.dld.2020.10.039
15 LIU X, DING B, SHI F,et al. The Efficacy and Safety of RemimazolamTosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial[J]. Drug Des Devel Ther, 2021, 15: 4675-4685. doi:10.2147/dddt.s339535
16 LIU M, SUN Y, ZHOU L,et al. The Median Effective Dose and Bispectral Index of RemimazolamTosilate for Anesthesia Induction in Elderly Patients: An Up-and-Down Sequential Allocation Trial[J]. Clin Interv Aging, 2022, 17: 837-843. doi:10.2147/cia.s364222
17 EISENRIED A, SCHüTTLER J, LERCH M,et al. Pharmacokinetics and Pharmacodynamics of Remimazolam(CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part II. Pharmacodynamics of Electroencephalogram Effects[J]. Anesthesiology,2020,132(4): 652-666. doi:10.1097/aln.0000000000003102
18 旷光华,徐伟,夏瑞. 瑞马唑仑的应用现状及其研究进展[J]. 实用医学杂志, 2022,38(13):1695-1700. doi:10.3969/j.issn.1006-5725.2022.13.025
19 吴宣,沈勤,胡文举. 瑞马唑仑对老年腹腔镜手术患者围术期应激反应和术后认知功能的影响[J]. 中国老年学杂志, 2023,43(17):4159-4163. doi:10.3969/j.issn.1005-9202.2023.17.019
Outlines

/