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NCT07131033
Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy
Phase 1, PHASE2 trial testing Esketamine in Laparoscopic Cholecystectomy in 120 participants. Participants enrolled and being followed up; not accepting new ones.
31 August 2025
Quick facts
| Lead sponsor | The Second People's Hospital of Huai'an |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 6 May 2025 |
| Primary completion | 31 August 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Esketamine (ESKETAMINE) — full drug profile →
- Magnesium sulfate — full drug profile →
- Esketamine and Magnesium sulfate — full drug profile →
- Saline
Conditions studied
- Laparoscopic Cholecystectomy — all drugs for Laparoscopic Cholecystectomy →
- Alleviate Postoperative Fatigue Syndrome — all drugs for Alleviate Postoperative Fatigue Syndrome →
Sponsor
The Second People's Hospital of Huai'an
Who can join
Adults 18 to 65, any sex, with Laparoscopic Cholecystectomy or Alleviate Postoperative Fatigue Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07131033
- Europe PMC full search
- ASCO Meeting Library
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Other recruiting trials for Laparoscopic Cholecystectomy
Currently open trials in the same condition.
- NCT07440940 — Timing of Subcostal TAPB Combined With Rectus Sheath Block for Postoperative Pain After Laparoscopic Cholecystectomy · NA · recruiting
- NCT07488078 — Effect of Liberal and Restrictive IV Fluids on Recovery After Gallbladder Surgery · Phase 1 · recruiting
- NCT06632184 — Peritoneal Lavage Using Saline or Saline With Ondansetron for Pain Control After Laparoscopic Cholecystectomy · Phase 4 · active not recruiting
- NCT07445854 — Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques · recruiting
- NCT07186803 — AI and Safety in Laparoscopic Cholecystectomy: A Randomized Controlled Trial · Phase 3 · recruiting
Other The Second People's Hospital of Huai'an trials
Trials by the same sponsor.
- NCT06920576 — Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal En · Phase 1, PHASE2 · active not recruiting
- NCT06457100 — Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Sur · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07131033 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second People's Hospital of Huai'an
- Last refreshed: 19 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07131033.
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