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Dexmedetomidine / Ureteral Stricture / Placebo administration · Phase 4 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 4 randomized controlled trial comparing perioperative dexmedetomidine-esketamine combination with placebo in patients undergoing laparoscopic ureteral reconstruction for ureteral stricture. The trial aims to test whether the drug combination reduces postoperative depressive symptoms and anxiety, but is not yet recruiting and has posted no results.
Phase 4, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Ureteral Stricture, Dexmedetomidine, Esketamine, Depressive Symptoms, Anxiety; age from 18 Years. Intervention: Combined dexmedetomidine-esketamine group. Compared with: Placebo group — Placebo Comparator. n = 658. 1 site: China.
Planned enrollment: 658 participants Primary outcome: prevalence of depressive symptoms at postoperative day 3 or before hospital discharge Intervention: combined low-dose dexmedetomidine-esketamine administration
Safety and cardiac tolerability data (bradycardia, hypotension risk mentioned in rationale) not yet collected or reported Rationale based on preliminary studies showing reduced postoperative depressive symptoms without increased adverse events with combination therapy
If results confirm the hypothesis, the dexmedetomidine-esketamine combination could offer a perioperative intervention to reduce postoperative depression and anxiety in this surgical population. However, clinicians should await completion and publication of results before considering clinical adoption.
This is a Phase 4 interventional trial registration with no results posted; the study is not yet recruiting and exists to test a hypothesis about a drug combination based on preliminary supporting data.
As stated by the source record.
Quoted from the source exactly as published.
If results confirm the hypothesis, the dexmedetomidine-esketamine combination could offer a perioperative intervention to reduce postoperative depression and anxiety in this surgical population. However, clinicians should await completion and publication of results before considering clinical adoption.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07753772). This is a study registration, not published results. Lead sponsor: Peking University First Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 658 participants (ESTIMATED). Conditions: Ureteral Stricture, Dexmedetomidine, Esketamine, Depressive Symptoms, Anxiety. Interventions: DRUG: Combined dexmedetomidine-esketamine administration; DRUG: Placebo administration. Primary outcome measures: Prevalence of depressive symptoms at postoperative day 3 / before discharge , At postoperative day 3 or before hospital discharge.. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.