Clinical Trial

Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy

Completed Phase 1/2
View on ClinicalTrials.gov →
Summary
Laparoscopic cholecystectomy (LC), while minimally invasive, triggers postoperative fatigue syndrome (POFS) through mechanisms including ischemia-reperfusion injury, neuroendocrine stress (sustained cortisol elevation), and inflammation-driven mitochondrial dysfunction (IDO-mediated kynurenine production). Esketamine, an NMDA receptor antagonist, counteracts POFS by blocking central sensitization, suppressing neuroinflammation (e.g., microglial IL-6 release), and enhancing neuroplasticity via BDNF/TrkB upregulation. Magnesium sulfate complements this by antagonizing NMDA/voltage-gated calcium channels to reduce inflammation and calcium overload, while optimizing cellular energy metabolism as an ATPase cofactor and alleviating muscle spasms. Crucially, their combination holds synergistic potential: esketamine targets central fatigue pathways, while magnesium addresses peripheral metabolic and muscular components. This study aims to determine their individual and interactive effects on POFS, recovery quality, and sleep outcomes in LC patients, establishing an efficient, safe strategy to accelerate postoperative rehabilitation.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-18.
Status change: Active, Not Recruiting → Completed 2026-07-02
Trial Details
NCT Number NCT07131033
Lead Sponsor The Second People's Hospital of Huai'an
Conditions Laparoscopic Cholecystectomy, Alleviate Postoperative Fatigue Syndrome
Enrollment 120 participants
Start Date 2025-09-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06