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NOT YET RECRUITING
NCT07753772
PHASE4

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

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

Official title: Perioperative Use of Dexmedetomidine-esketamine Combination on Depression and Anxiety in Patients Undergoing Laparoscopic Ureteral Reconstruction: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

658

Start Date

2026-08

Completion Date

2029-08

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

DRUG

Combined dexmedetomidine-esketamine administration

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.

DRUG

Placebo administration

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China