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

NCT07753772 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-1344
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Stricture; Dexmedetomidine; Esketamine; Depressive Symptoms; Anxiety

Keywords

Laparoscopic ureteral reconstruction; Dexmedetomidine; Esketamine; Depressive symptoms; Anxiety

Outcome Measures

Primary Outcomes (1)

• Prevalence of depressive symptoms at postoperative day 3 / before discharge

  Depressive symptoms will be screened using the Patient Health Questionnaire-9 (PHQ-9; total scores range from 0 to 27, with higher scores indicating more severe symptoms). A PHQ-9 score ≥5 is defined as pesence of depressive symptoms.

  At postoperative day 3 or before hospital discharge.

Secondary Outcomes (3)

• Incidence of moderate-to-severe catheter-related bladder discomfort (CRBD) within 24 hours after surgery

  Up to 24 hours after surgery.

• Prevalence of anxiety symptoms at postoperative day 3 / before discharge

  At postoperative day 3 or before hospital discharge.

• Prevalence of depressive symptoms at 30 days after surgery

  At 30 days after surgery.

Other Outcomes (7)

• Area under curve (AUC) of pain intensity within 48 hours after surgery

  Within 48 hours after surgery.

• Percentage using rescue analgesics within 48 hours after surgery

  Within 48 hours after surgery.

• Subjective sleep quality on the night of surgery and the first postoperative night

  From the night of surgery until the first night after surgery.

Study Arms (2)

Combined dexmedetomidine-esketamine group

EXPERIMENTAL

During anesthesia, a loading dose (0.8 ml/kg/h) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 1 ug/ml; ESK 0.5 mg/ml) will be infused after anesthesia induction for 30 min (DEX 0.4 ug/kg; ESK 0.2 mg/kg), followed by a continuous infusion at 0.1 ml/kg/h (DEX 0.1 ug/kg/h; ESK 0.05 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.25 mg/ml), and sufentanil (1.0 ug/ml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 0.5 mg, and sufentanil 2.0 ug) with an 8-minute lockout interval and a 1-ml/h (DEX 1.5 ug/h, ESK 0.25 mg/h, and sufentanil 1.0 ug/h) background infusion, and used for up to 48 hours.

Drug: Combined dexmedetomidine-esketamine administration

Placebo group

PLACEBO COMPARATOR

During anesthesia, a loading dose (0.8 ml/kg/h) of normal saline will be infused after anesthesia induction for 30 min, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1.0 ug/ml), programmed to deliver 2-ml boluses (sufentanil 2.0 ug) with an 8-minute lockout interval and a 1-ml/h (sufentanil 1.0 ug/h ) background infusion, and used for up to 48 hours.

Drug: Placebo administration

Interventions

Placebo administration DRUG

During anesthesia, a loading dose (0.8 ml/kg/h) of normal saline will be infused after anesthesia induction for 30 min, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1.0 ug/ml), programmed to deliver 2-ml boluses (sufentanil 2.0 ug) with an 8-minute lockout interval and a 1-ml/h (sufentanil 1.0 ug/h ) background infusion, and used for up to 48 hours.

Placebo group

Combined dexmedetomidine-esketamine administration DRUG

During anesthesia, a loading dose (0.8 ml/kg/h) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 1 ug/ml; ESK 0.5 mg/ml) will be infused after anesthesia induction for 30 min (DEX 0.4 ug/kg; ESK 0.2 mg/kg), followed by a continuous infusion at 0.1 ml/kg/h (DEX 0.1 ug/kg/h; ESK 0.05 mg/kg/h) until 1 hour before the expected end of surgery. After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.25 mg/ml), and sufentanil (1.0 ug/ml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 0.5 mg, and sufentanil 2.0 ug) with an 8-minute lockout interval and a 1-ml/h (DEX 1.5 ug/h, ESK 0.25 mg/h, and sufentanil1.0 ug/h ) background infusion, and used for up to 48 hours.

Combined dexmedetomidine-esketamine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Preoperative inability to communicate due to coma, delirium, severe dementia, or language barrier;
• History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
• 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;
• Uncontrolled hyperthyroidism or history of pheochromocytoma;
• Severe hepatic insufficiency (Child-Pugh Class C), severe renal insufficiency (required preoperative dialysis), or American Society of Anesthesiologists (ASA) physical status classification ≥ IV;
• Allergy to dexmedetomidine and/or esketamine;
• Other conditions deemed unsuitable for study participation by the investigators.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (34)

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Dong-Xin Wang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

8610 83572784; wangdongxin@hotmail.com

Chun-Qing Li, MD

CONTACT

8610 83575138; lichuntsing@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)