Perioperative medicine & outcomes
Effect of intraoperative remimazolam infusion on postoperative sleep disturbance in elderly patients after gynecological laparoscopy: A randomized clinical trial
Authors' conclusion
This study suggested the prophylactic effect of intraoperative remimazolam infusion on the incidence of PSD in elderly patients who underwent gynecological laparoscopic surgery.
Study context
- Population
- Patients aged ≥ 65 years undergoing elective gynecological laparoscopic surgery146 included
- Participants
- 76 vs 76
- Comparison
- Remimazolam vs Control
- Remimazolamn = 76
- Controln = 76reference
- Primary endpoint
- Incidence of PSD (NRS score ≥ 6 or Athens Insomnia Scale score ≥ 6)
- Follow-up
- POD 1 or 3
Methodological detailssingle-centre, Third Affiliated Hospital of Sun Yat-sen University, March to October 2024
- Single-centre
- Third Affiliated Hospital of Sun Yat-sen University, March to October 2024
Primary result
As reported in the abstract
PSD · POD1
P = 0.002
Further findings
Postoperative sleep disturbance (PSD) at POD1, per-protocol analysis
- Similar trend to ITT (52.1% versus 24.7%)
- P = 0.001
- Per-protocol
PSD at POD3, per-protocol analysis
- Similar trend to ITT (30.1% versus 6.8%)
- P < 0.001
- Per-protocol
Safety
Hypotension (ITT) · ITT
P = 0.005
Hypotension (per-protocol) · per-protocol
P = 0.016
Bradycardia (ITT) · ITT
P = 0.021
Bradycardia (per-protocol) · per-protocol
P = 0.027
Original publication
Effect of intraoperative remimazolam infusion on postoperative sleep disturbance in elderly patients after gynecological laparoscopy: A randomized clinical trial. Anaesth Crit Care Pain Med. Published 29 September 2025. doi:10. 1016/ j. accpm. 2025. 101625
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