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Dexmedetomidine-Esketamine Combination on Depression and Anxiety After Laparoscopic Ureteral Reconstruction

Not Yet RecruitingPhase 4

Sponsor: Peking University First Hospital

Conditions: Ureteral Stricture, Dexmedetomidine, Esketamine, Depressive Symptoms, Anxiety

Interventions: Combined dexmedetomidine-esketamine administration, Placebo administration

Countries: China

Anxiety and depressive symptoms are prevalent in patients undergoing surgical repair for ureteral stricture, driven by chronic pain, renal function concerns, and surgical uncertainty. Dexmedetomidine has anxiolytic and antidepressant effects but may increase bradycardia and hypotension; esketamine provides rapid antidepressant efficacy but may cause psychiatric side effects. Preliminary studies showed that combined use of low-dose dexmedetomidine and esketamine reduced the prevalence of postoperative depressive symptoms without increasing adverse events. This study is designed to test the hypothesis that perioperative use of low-dose dexmedetomidine-esketamine combination may relieve postoperative depressive symptoms and anxiety in patients undergoing laparoscopic ureteral reconstruction.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Aged ≥ 18 years;
2. Diagnosed with ureteral stricture and scheduled for elective laparoscopic ureteral reconstruction under general anesthesia;
3. Requiring patient-controlled intravenous analgesia after surgery.

Exclusion Criteria:

1. Preoperative inability to communicate due to coma, delirium, severe dementia, or language barrier;
2. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
3. Presence of preexisting left ventricular ejection fraction (LVEF) \< 30%, sick sinus syndrome, severe sinus bradycardia (heart rate \< 50 beats/min), or atrioventricular block above grade II without pacemaker implanted;
4. Uncontrolled hyperthyroidism or history of pheochromocytoma;
5. Severe hepatic insufficiency (Child-Pugh Class C), severe renal insufficiency (required preoperative dialysis), or American Society of Anesthesiologists (ASA) physical status classification ≥ IV;
6. Allergy to dexmedetomidine and/or esketamine;
7. Other conditions deemed unsuitable for study participation by the investigators.

Locations (1)

Beijing, Beijing Municipality, China