Clinical Trial Comparing Remimazolam with Propofol During Intravenous Anesthesia: A Prospective Randomised Clinical Trial


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Abstract

Background and Objective:Remimazolam is a water-soluble sedative-anesthetic with short-acting properties and less hemodynamic effects. Currently, it is primarily used for gastroenteroscopy sedation.

Aim:The aim of this study is to investigate the effectiveness and safety of Remimazolam as an alternative intravenous anesthetic agent in surgical patients, in order to expand clinical options beyond Propofol.

Methods:Eighty patients aged 20-69 and classified as an American Society of Anesthesiologists physical status I-II were randomly assigned to either the Remimazolam group (RM group) or the Propofol group (PR group) for anesthesia induction and maintenance. Hemodynamics and Bispectral Index (BIS) were recorded before and after anesthesia, along with other relevant indices such as the time, to loss of consciousness (LoC), operation time, anesthesia time, awakening time, the number of cases of injection site pain. Additionally, the Ramsay sedation score, intraoperative awareness, dreaming, and postoperative adverse events were also assessed.

Results:After anesthesia, both groups experienced a significant decrease in blood pressure compared to baseline values, however, the reduction in blood pressure was less significant in the RM group than in the PR group (P(<0.05). The heart rate of patients in the RM group remained relatively stable at all time points. There were significantly more cases of injection site pain and use of pressor or atropine during operation observed in the PR group compared to the RM group (P(<0.05). There were no significant differences between the two groups in terms of time to loss of consciousness, anesthesia time, operation time, awakening time, and intraoperative awareness (P>0.05). However, at 5 and 30 minutes after awakening, the Ramsay sedation score was significantly better in the RM group compared to the PR group (P(<0.05).

Conclusion:When remimazolam is used for intravenous anesthesia induction and maintenance, it can achieve a favorable anesthetic effect while maintaining a relatively stable blood pressure and heart rate. Patients experience shorter awakening times (8.3±3.7 min), better awakening quality (5 min Ramsay sedation score is 2 points ), and no intraoperative awareness.

Trial Registration Number:AF SOP/3.6-01/5.1.

About the authors

Lu Yang

Department of Anesthesiology, General Hospital of the Yangtze River Shipping

Email: info@benthamscience.net

Jin Zhang

School of economics, Peking University

Email: info@benthamscience.net

Nengke Xiao

Muse College, The Chinese University of Hong Kong

Email: info@benthamscience.net

Junjie Chen

Department of Statistical Science, University College London

Email: info@benthamscience.net

Hengjuan Liu

Department of Anesthesiology, Renmin Hospital of Wuhan University

Email: info@benthamscience.net

Xuan He

Department of Anesthesiology, Renmin Hospital of Wuhan University

Author for correspondence.
Email: info@benthamscience.net

Xingpeng Xiao

Department of Anesthesiology, Renmin Hospital, Renmin Hospital of Wuhan University

Author for correspondence.
Email: info@benthamscience.net

Fan Zhang

Department of Anesthesiology,, Renmin Hospital of Wuhan University

Author for correspondence.
Email: info@benthamscience.net

References

  1. Birgenheier, N.M.; Stuart, A.R.; Egan, T.D. Soft drugs in anesthesia: remifentanil as prototype to modern anesthetic drug development. Curr. Opin. Anaesthesiol., 2020, 33(4), 499-505. doi: 10.1097/ACO.0000000000000879 PMID: 32530892
  2. Sahinovic, M.M.; Struys, M.M.R.F.; Absalom, A.R. Clinical pharmacokinetics and pharmacodynamics of propofol. Clin. Pharmacokinet., 2018, 57(12), 1539-1558. doi: 10.1007/s40262-018-0672-3 PMID: 30019172
  3. Wesolowski, A.M.; Zaccagnino, M.P.; Malapero, R.J.; Kaye, A.D.; Urman, R.D. Remimazolam: Pharmacologic considerations and clinical role in anesthesiology. Pharmacotherapy, 2016, 36(9), 1021-1027. doi: 10.1002/phar.1806 PMID: 27496519
  4. Schüttler, J.; Eisenried, A.; Lerch, M.; Fechner, J.; Jeleazcov, C.; Ihmsen, H. Pharmacokinetics and pharmacodynamics of remimazolam (CNS 7056) after continuous infusion in healthy male volunteers. Anesthesiology, 2020, 132(4), 636-651. doi: 10.1097/ALN.0000000000003103 PMID: 31972655
  5. Cardia, L. Remimazolam: an ultrashort-acting intravenous anesthetic suitable for general anesthesia. Minerva Anestesiol., 2021, 87(10), 1059-1063. doi: 10.23736/S0375-9393.21.16006-7 PMID: 34337928
  6. Xiao, X.; Xiao, N.; Zeng, F.; Chen, H.; Zhang, L.; He, X. Gastroscopy sedation: clinical trial comparing propofol and sufentanil with or without remimazolam. Minerva Anestesiol., 2022, 88(4), 223-229. doi: 10.23736/S0375-9393.21.15917-6 PMID: 35072431
  7. Rex, D.K.; Bhandari, R.; Lorch, D.G.; Meyers, M.; Schippers, F.; Bernstein, D. Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial. Dig. Liver Dis., 2021, 53(1), 94-101. doi: 10.1016/j.dld.2020.10.039 PMID: 33243567
  8. Doi, M.; Hirata, N.; Suzuki, T.; Morisaki, H.; Morimatsu, H.; Sakamoto, A. 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. Anesth., 2020, 34(4), 491-501. doi: 10.1007/s00540-020-02776-w PMID: 32303884
  9. Dai, G.; Pei, L.; Duan, F.; Liao, M.; Zhang, Y.; Zhu, M.; Zhao, Z.; Zhang, X. Safety and efficacy of remimazolam compared with propofol in induction of general anesthesia. Minerva Anestesiol., 2021, 87(10), 1073-1079. doi: 10.23736/S0375-9393.21.15517-8 PMID: 34263581
  10. Hemphill, S.; McMenamin, L.; Bellamy, M.C. Hopkins, PM Propofol infusion syndrome: a structured literature review and analysis of published case reports. Br. J. Anaesth., 2019, 122(4), 448-459. doi: 10.1016/j.bja.2018.12.025
  11. Adler, A.C. Propofol: Review of potential risks during administration. AANA J., 2017, 85(2), 104-107. PMID: 30501158
  12. Erdoes, G.; Basciani, R.M.; Eberle, B. Etomidate - a review of robust evidence for its use in various clinical scenarios. Acta Anaesthesiol. Scand., 2014, 58(4), 380-389. doi: 10.1111/aas.12289 PMID: 24588359
  13. Ye, L.; Xiao, X.; Zhu, L. The comparison of etomidate and propofol anesthesia in patients undergoing gastrointestinal endoscopy: A systematic review and meta-analysis. Surg. Laparosc. Endosc. Percutan. Tech., 2017, 27(1), 1-7. doi: 10.1097/SLE.0000000000000373 PMID: 28079763
  14. Valk, B.I. Struys, MMRF Etomidate and its Analogs: A Review of Pharmacokinetics and Pharmacodynamics. Clin. Pharmacokinet., 2021, 60(10), 1253-1269. doi: 10.1007/s40262-021-01038-6
  15. Morimoto, Y. Efficacy and safety profile of remimazolam for sedation in adults undergoing short surgical procedures. Ther. Clin. Risk Manag., 2022, 18(2), 95-100. doi: 10.2147/TCRM.S304556 PMID: 35140469
  16. Kim, K.M. Remimazolam: Pharmacological characteristics and clinical applications in anesthesiology. Anesth. Pain Med., 2022, 17(1), 1-11. doi: 10.17085/apm.21115 PMID: 35139608
  17. Shirozu, K.; Nobukuni, K.; Tsumura, S.; Imura, K.; Nakashima, K.; Takamori, S.; Higashi, M.; Yamaura, K. Neurological sedative indicators during general anesthesia with remimazolam. J. Anesth., 2022, 36(2), 194-200. doi: 10.1007/s00540-021-03030-7 PMID: 34999964
  18. Veselis, R.A.; Reinsel, R.A.; Feshchenko, V.A. Wroński, M. The comparative amnestic effects of midazolam, propofol, thiopental, and fentanyl at equisedative concentrations. Anesthesiology, 1997, 87(4), 749-764. doi: 10.1097/00000542-199710000-00007 PMID: 9357875
  19. Bulach, R.; Myles, P.S.; Russnak, M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br. J. Anaesth., 2005, 94(3), 300-305. doi: 10.1093/bja/aei040 PMID: 15567810
  20. Heavner, M.S.; Gorman, E.F.; Linn, D.D.; Yeung, S.Y.A.; Miano, T.A. Systematic review and meta-analysis of the correlation between bispectral index (BIS) and clinical sedation scales: Toward defining the role of BIS in critically ill patients. Pharmacotherapy, 2022, 42(8), 667-676. doi: 10.1002/phar.2712 PMID: 35707961
  21. Olotu, C. Postoperative neurocognitive disorders. Curr. Opin. Anaesthesiol., 2020, 33(1), 101-108. doi: 10.1097/ACO.0000000000000812 PMID: 31764008
  22. Tan, Y.; Ouyang, W.; Tang, Y.; Fang, N.; Fang, C.; Quan, C. Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy. J. Gastroenterol. Hepatol., 2022, 37(3), 576-583. doi: 10.1111/jgh.15761 PMID: 34907594

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