A self-controlled trial comparing remimazolam to propofol for sedation in cervical cancer patients during interstitial brachytherapy 

Abstract

Background This study aimed to compare the efficacy and safety of remimazolam and propofol when administered to the same patient. Methods Employing a self-controlled trial design, this study evaluated the effects of various sedative regimens on patients with cervical cancer undergoing interstitial brachytherapy. A total of 32 patients were included in the study. Following the administration of sufentanil 0.1 µg/kg, each patient were randomly assigned to one of three sedative regimens: propofol 1.5mg/kg (P), remimazolam 0.3mg/kg (R1), or remimazolam 0.2mg/kg (R2). The depth of anesthesia was monitored using the Narcotrend, and the operation commenced when the Narcotrend index (NI) dropped to 64 or the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S)reached ≤ 2. The study noted the success rate of initial sedation, onset time, and maintenance time of sedation during interstitial brachytherapy. Adverse events such as hypoxemia, hypotension, and injection pain were also recorded. Additionally, the total dosage of remimazolam was documented. Results The success rate of initial sedation with R2 was notably lower than with P and R1 (p < 0.001). R1 had a significantly longer onset time and a notably shorter maintenance time of sedation compared with P (p < 0.05). However, no significant difference was observed in the total dosage of remimazolam administered and operation duration during sedation with R1 and R2 (p > 0.05). Remimazolam led to a significant reduction in the incidence of hypoxemia, hypotension, and injection pain (p < 0.05). Conclusion The combination of remimazolam 0.3mg/kg with sufentanil exhibited an improved sedative effect in cervical cancer patients undergoing interstitial brachytherapy. It had minimal effects on respiration and circulation, establishing it as a safe option for this procedure. Trial Registration Chinese Clinical Trial Registry (ChiCTR2200065938, 11/18/2022).