NCT06900205

Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery

Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery: A Multi-Center Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Postoperative delirium (POD) is a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality. Meanwhile,sleep disorders are not only an important predisposing factor for delirium,but also one of the main symptoms of delirium.Systemic inflammatory responses caused by sleep disorders may be an important mechanism for POD. Many studies have shown that esketamie may inhibit inflammatory factors and enhance neuroplasticity. In summary,we felt the need to further explore the therapeutic potential of esketamine in the area of POD as well as postoperative sleep disorders.

Conditions

• Postoperative Delirium (POD)
• Postoperative Sleep Disturbance

Interventions

Type	Name	Description
DRUG	Esketamine	loading dose:intravenous infusion of 0.25mg/kg esketamine after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail+1mg/kg esketamine diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.
DRUG	0.9 % saline	loading dose:intravenous infusion the same volume of 0.9% saline as the other group after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-03-30
• Completion: 2026-09-30
• First posted: 2025-03-28
• Last updated: 2025-05-16

Locations

1 site across 1 country: China