Comparison of remimazolam tosilate and propofol during induction and maintenance of general anesthesia in patients undergoing laparoscopic cholecystectomy: a prospective, single center, randomized controlled trial.

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  • Author(s): Luo Z;Luo Z; Cao H; Cao H; Luo L; Luo L; Chen L; Chen L; Feng D; Feng D; Huang G; Huang G
  • Source:
    BMC anesthesiology [BMC Anesthesiol] 2024 Jul 06; Vol. 24 (1), pp. 226. Date of Electronic Publication: 2024 Jul 06.
  • Publication Type:
    Journal Article; Randomized Controlled Trial; Comparative Study; Research Support, Non-U.S. Gov't
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968535 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2253 (Electronic) Linking ISSN: 14712253 NLM ISO Abbreviation: BMC Anesthesiol Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2001-
    • Subject Terms:
      Propofol*/administration & dosage ; Cholecystectomy, Laparoscopic*/methods ; Anesthesia, General*/methods ; Benzodiazepines*/administration & dosage ; Anesthetics, Intravenous*/administration & dosage; Humans ; Female ; Male ; Prospective Studies ; Middle Aged ; Adult
    • Abstract:
      Background: Remimazolam tosilate (RT) is a new, ultrashort-acting benzodiazepine. Here, we investigated the efficacy and safety of RT for general anesthesia in patients undergoing Laparoscopic Cholecystectomy (LC).
      Methods: In this study, 122 patients undergoing laparoscopic cholecystectomy were randomly allocated to receive either remimazolam tosilate (Group RT) or propofol group (Group P). RT was administered as a slow bolus of 0.3 mg kg - 1 for induction, followed by 1.0-2.0 mg kg - 1 h - 1 for maintenance of general anesthesia. Propofol was started at 2 mg kg - 1 and followed by 4-10 mg kg - 1 h - 1 until the end of surgery. The primary outcome was the time to bispectral index (BIS) ≤ 60. The secondary outcome included the time to loss of consciousness (LoC), and the time to extubation. Adverse events were also assessed.
      Results: A total of 112 patients were recruited for study participation. Among them, the time to BIS ≤ 60 in Group RT was longer than that in Group P (Group RT: 89.3 ± 10.7 s; Group P: 85.9 ± 9.7 s, P > 0.05). While the time to LoC comparing remimazolam and propofol showed no statistical significance (Group RT: 74.4 ± 10.3 s; Group P: 74.7 ± 9.3 s, P > 0.05). The time to extubation in Group RT was significantly longer than that in Group P (Group RT: 16.0 ± 2.6 min; Group P: 8.8 ± 4.3 min, P < 0.001). Remimazolam tosilate had more stable hemodynamics and a lower incidence of hypotension during general anesthesia.
      Conclusions: Remimazolam tosilate can be safely and effectively used for general anesthesia in patients undergoing Laparoscopic Cholecystectomy. It maintains stable hemodynamics during induction and maintenance of general anesthesia compared with propofol. Further studies are needed to validate the findings.
      Trial Registration: Chictr.org.cn ChiCTR2300071256 (date of registration: 09/05/2023).
      (© 2024. The Author(s).)
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    • Grant Information:
      Zunyi City KEHE HZ(2020)288 the Science and Technology Bureau of Zunyi City; Zunyi City KEHE HZ(2020)288 the Science and Technology Bureau of Zunyi City; Zunyi City KEHE HZ(2020)288 the Science and Technology Bureau of Zunyi City; Zunyi City KEHE HZ(2020)288 the Science and Technology Bureau of Zunyi City; Zunyi City KEHE HZ(2020)288 the Science and Technology Bureau of Zunyi City; Zunyi City KEHE HZ(2020)288 the Science and Technology Bureau of Zunyi City
    • Contributed Indexing:
      Keywords: Propofol; Remimazolam tosilate; Total intravenous anesthesia
    • Molecular Sequence:
      ChiCTR ChiCTR2300071256
    • Accession Number:
      YI7VU623SF (Propofol)
      12794-10-4 (Benzodiazepines)
      7V4A8U16MB (remimazolam)
      0 (Anesthetics, Intravenous)
    • Publication Date:
      Date Created: 20240706 Date Completed: 20240706 Latest Revision: 20241108
    • Publication Date:
      20241109
    • Accession Number:
      PMC11227182
    • Accession Number:
      10.1186/s12871-024-02614-6
    • Accession Number:
      38971731