NCT04425473

Esketamine and Perioperative Depressive Symptoms

Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.

Conditions

• Depressive Symptoms
• Esketamine
• Perioperative Complication
• Major Surgery

Interventions

Type	Name	Description
DRUG	Esketamine	Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
DRUG	Normal saline	Equivalent amount of normal saline will be administrated intravenously suturing incision.

Timeline

• Start date: 2021-02-19
• Primary completion: 2024-06-23
• Completion: 2024-11-27
• First posted: 2020-06-11
• Last updated: 2025-08-01

Locations

1 site across 1 country: China