Active — Not RecruitingPhase 1/2

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

China120 participantsStarted 2025-05-06

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 65 years * American Society of Anesthesiologists (ASA) classification I-II * Patients scheduled for LC under general anaesthesia and with a procedure duration of less than 60 minutes. Exclusion Criteria: * Patients who do not sign the informed consent; * patients with severe diseases of major organs such as the heart, brain, lungs, liver, and kidneys; * patients with adverse drug reactions to esketamine or magnesium sulfate; * patients with uncontrolled hypertension or hyperthyroidism; * patients with endocrine and metabolic diseases or neurological diseases; * pregnant or lactating women; * long-term users of sedatives, analgesics, or long-term alcohol abusers; * patients with a history of mental illness, language communication barriers, or inability to understand the content of the experiment; * patients with difficult airways during anesthesia induction requiring a change in the conventional intubation method; * patients with sinus bradycardia or atrioventricular block; * patients with concurrent cholangitis, biliary obstruction, or pancreatitis.

What they're measuring

Christensen's Fatigue Scale

Timeframe: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)

Identity-Consequence Fatigue Scale

Timeframe: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)

Trial details

NCT IDNCT07131033

SponsorThe Second People's Hospital of Huai'an

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Laparoscopic Cholecystectomy trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Christensen's Fatigue Scale

Timeframe: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)

Identity-Consequence Fatigue Scale

Timeframe: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)