A recent study published in Drug Design, Development and Therapy has found that remimazolam is non-inferior to propofol for anesthesia satisfaction in women undergoing outpatient gynecological surgery. The single-center, open-label, non-inferiority, randomized clinical trial, conducted at the First Affiliated Hospital of Zhengzhou University in China, compared the two sedatives in 168 patients undergoing minor gynecological procedures.
The primary endpoint was the immediate postoperative anesthesia satisfaction score, assessed using the Iowa Satisfaction with Anesthesia Scale (ISAS). Secondary endpoints included anesthesia satisfaction on postoperative day 1, injection pain, sedation success rate, pain and nausea scores, time to alertness, PACU stay length, clinician satisfaction, sleep quality, and anxiety and depression scores.
Key Findings
The study demonstrated that remimazolam was non-inferior to propofol in terms of immediate postoperative anesthesia satisfaction. The mean ISAS scores immediately after surgery were 1.7 (0.6) in the remimazolam group and 2.0 (0.7) in the propofol group (unadjusted difference, -0.2; 97.5% CI: -0.5 to -0.0, p = 0.02). Subgroup analyses did not reveal any significant interactions between treatment assignment and subgroups.
High-intensity injection pain was significantly less common in the remimazolam group (3.6%) compared to the propofol group (45.2%; p < 0.001). However, the remimazolam group exhibited a significantly prolonged PACU stay (27.6 min vs 22.4 min; p < 0.001) and longer durations from drug administration to discharge (p < 0.001).
Interestingly, postoperative nausea scores were significantly higher in the remimazolam group both immediately after surgery (p = 0.01) and on postoperative day 1 (p = 0.01). Furthermore, on postoperative day 1, the remimazolam group reported higher pain scores (p = 0.02), poorer sleep quality (p < 0.001), and increased anxiety and depression scores (p < 0.05).
Implications for Clinical Practice
While remimazolam offers the advantage of reduced injection pain, clinicians should be aware of the potential for prolonged PACU stays and increased postoperative nausea, pain, anxiety, and depression. The study highlights the importance of considering patient-centered outcomes, such as anesthesia satisfaction, in the selection of sedative agents for outpatient gynecological procedures.
Study Limitations
The authors acknowledge several limitations, including the single-center design, potential for bias due to unblinded anesthesiologists, and limited generalizability due to the specific patient population and types of procedures included. The study also notes that deeper levels of sedation, influenced by local practice, may limit the generalizability of the results.
Conclusion
Despite these limitations, the study suggests that remimazolam is a viable alternative to propofol for sedation in outpatient gynecological surgery, particularly for patients who may be more sensitive to injection pain. Further research is needed to confirm these findings in larger, multi-center studies and to investigate strategies for mitigating the potential for increased postoperative nausea and psychological distress.
