Cardiopulmonary Adverse Events of Remimazolam versus Propofol During Cervical Conization: A Randomized Controlled Trial

Drug Des Devel Ther. 2023 Apr 22:17:1233-1243. doi: 10.2147/DDDT.S405057. eCollection 2023.

Abstract

Purpose: This study aimed to compare the cardiopulmonary safety of remimazolam and propofol in patients undergoing cervical conization.

Methods: This was a single-blind, parallel, randomized controlled study. A total of 204 patients scheduled for day surgery of cold knife cervical conization received either remimazolam-alfentanil anesthesia (remimazolam group) or propofol-alfentanil anesthesia (propofol group). The primary outcome was the incidence of intraoperative cardiopulmonary adverse events (a composite outcome of hypotension, bradycardia and hypoxemia). The occurrence of hypotension, bradycardia, hypoxemia and the degree of body movement were secondary outcomes, as well as the moment at which consciousness was lost, the interval between the end of anesthesia and the operating room's release of the patient, and the overall dosage of alfentanil administered during the procedure.

Results: The incidence of intraoperative cardiopulmonary adverse events was 45 (44.1%) in the remimazolam group and 72 (70.6%) in the propofol group (absolute risk difference [95% CI], -26.47% [-39.55% to -13.39%]; odds ratio (OR) [95% CI], 0.43 [0.28 to 0.65]; P < 0.001). The remimazolam group showed lower incidences of hypotension and hypoxemia compared to the propofol group (P = 0.01 for both). No significant differences were observed in the overall alfentanil dosages administered, bradycardia, bodily movement, or time to losing consciousness between the two groups.

Conclusion: In patients who underwent cold knife cervical conization, remimazolam-alfentanil anesthesia was associated with a reduced incidence of intraoperative cardiopulmonary adverse events compared with propofol-alfentanil anesthesia.

Keywords: adverse events; alfentanil; cervical conization; general anesthesia; propofol; remimazolam.

Publication types

  • Randomized Controlled Trial
  • Case Reports
  • Clinical Trial

MeSH terms

  • Alfentanil / adverse effects
  • Anesthetics, Intravenous
  • Benzodiazepines
  • Bradycardia / chemically induced
  • Conization
  • Humans
  • Hypotension* / chemically induced
  • Hypoxia
  • Propofol* / adverse effects
  • Single-Blind Method

Substances

  • Propofol
  • Alfentanil
  • Anesthetics, Intravenous
  • remimazolam
  • Benzodiazepines

Grants and funding

The authors have no funding in this work.