Effect of intraoperative remimazolam infusion on postoperative sleep disturbance in elderly patients after gynecological laparoscopy: A randomized clinical trial.

Abstract

Background: Postoperative sleep disturbance (PSD) is prevalent among elderly patients and women undergoing surgery. This study aimed to investigate the efficacy and safety of remimazolam in preventing PSD in elderly patients undergoing gynecological laparoscopic surgery.

Methods: This randomized controlled trial was conducted at the Third Affiliated Hospital of Sun Yat-sen University between March to October 2024. Patients aged ≥ 65 years undergoing elective surgery were randomized to the control group (anesthesia induction and intraoperative infusion with propofol) or the remimazolam group (anesthesia induction and intraoperative infusion with remimazolam). The primary outcome was the incidence of PSD, defined as a Numeric Rating Scale score ≥ 6 or an Athens Insomnia Scale score ≥ 6 at either postoperative day (POD) 1 or 3.

Results: The study included 146 patients. In intention-to-treat (ITT) analysis, PSD rates at POD1 were 51.3% (39/76) for controls versus 26.3% (20/76) for remimazolam (P =  0.002); at POD3, rates were 31.6% (24/76) versus 9.2% (7/76) (P =  0.001). Per-protocol (PP) analysis showed similar trends (POD1: 52.1% versus 24.7%, P =  0.001; POD3: 30.1% versus 6.8%, P <  0.001). Furthermore, compared to the control group, the remimazolam group demonstrated a lower incidence of hypotension (ITT, 34.2% versus 14.5%, P =  0.005; PP, 34.2% versus 13.7%, P =  0.016) and bradycardia (ITT, 21.1% versus 7.9%, P = 0.021; PP, 19.2% versus 6.8%, P =  0.027).

Conclusions: This study suggested the prophylactic effect of intraoperative remimazolam infusion on the incidence of PSD in elderly patients who underwent gynecological laparoscopic surgery.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2400081855.