A Phase 4 interventional study of Combined dexmedetomidine-esketamine administration and Placebo administration in Ureteral Stricture, Dexmedetomidine and Esketamine, sponsored by Peking University First Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Treatment
Among 357 studies in Depression with a site in China — 118 open to participants now, 137 under way, 3 of them phase 3. Depression · China.
Among the 357 studies in Depression with a site in China, this one is the 19th largest by planned enrollment of the 283 interventional ones that give a count, is one of 38 that started in 2026, is one of 24 in phase 4, reaches primary completion later than 131 of the 136 other live ones, and was the 349th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →118 of the 357 studies in Depression with a site in China are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in China, United States, Australia and 12 more countries
Ages 18–75
Xidian University · Sites in China
Ages 18–30 · Healthy volunteers
Peking University · Sites in China
Ages 18–50
Tianjin Medical University · Sites in China
Ages 18–90 · Healthy volunteers
Moon (Guangzhou) Biotechnology Co., Ltd. · Sites in China
Ages 18–60
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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357 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 20 · Phase 3 13 · Phase 4 24
First in 2006; this study’s year is marked. 38 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 658 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Median enrollment 132 across the 283 interventional studies, 306 across the 74 observational. Of the 140 that completed or were terminated, 9 (6%) have results posted.
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20 of 357 have an industry lead sponsor. The 10 most frequent:
Peking University First Hospital is the lead sponsor of 391 studies on the registry; 186 are open to participants now.
Peking University First Hospital has 4 studies filed under Depression — fewer than ten, so there is no comparison to draw.
43 of the studies in Depression with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07485595Phase 3Tasly Pharmaceutical Group Co., LtdA Study of the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression | 2026-12-31 |
| NCT07738809Capital University of Physical Education and Sports, ChinaEffects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms | 2026-11 |
| NCT07179913The First Hospital of Jilin UniversityThe Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression | 2026-11-20 |
| NCT07247968Min SuSubanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study | 2026-11-20 |
| NCT07282366Jian-Jun OuVideo Intervention to Reduce Depression-related Stigma Among Adolescents | 2026-11-20 |
Add all 43 to your calendar (.ics) → With an account.
Among the 357 studies in Depression with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Ureteral stricture (US) is characterized by narrowing of the ureteral lumen, which can lead to upper urinary tract obstruction and subsequent renal impairment. The primary therapeutic goal of US is to relieve obstruction and preserve renal function. Current treatment methods include endoscopic balloon dilation, endoureterotomy, ureteral dilation, and ureteral reconstruction surgery. Among these, ureteral reconstruction surgery is highly effective, especially for complex strictures exceeding 2 cm in length.
Patients with US often endure prolonged symptom burden and substantial medical costs, and are prone to emotional disturbances such as anxiety and depression. A multicenter prospective study reported that the preoperative prevalence of anxiety and depressive syndromes in US patients scheduled for surgery was 31.3% and 20.7%, respectively, with iatrogenic US and urinary symptoms being the strongest predictors of increased levels of anxiety and depression. Perioperative stress may further exacerbate the severity of anxiety and depressive symptoms, leading to increased intraoperative anesthetic and analgesic requirements, delayed emergence from anesthesia, and higher risks of postoperative delirium and sleep disturbances.
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, analgesic, and anxiolytic properties. It also exerts antidepressant effects through multiple mechanisms. Clinical studies have confirmed its efficacy in alleviating postoperative anxiety and depression across various surgical populations. Esketamine, the S-enantiomer of ketamine, is an N-methyl-D-aspartate (NMDA) receptor antagonist with anesthetic, analgesic, and rapid-onset antidepressant effects. Perioperative studies also confirmed the efficacy of esketamine in relieving postoperative depressive symptoms.
Routine dose esketamine may cause psychiatric side effects such as dissociative symptoms and hallucinations; administration of low-dose esketamine attenuates these side effects but may weaken the antidepressant efficacy. The sedative properties of dexmedetomidine can mitigate the side effects of esketamine. Furthermore, the combined use of low-dose dexmedetomidine and esketamine may offer synergistic anxiolytic and antidepressant effects with a favorable safety profile.
This study is designed to test the hypothesis that perioperative administration of low-dose dexmedetomidine-esketamine combination may relieve postoperative depressive and anxiety symptoms in patients undergoing laparoscopic ureteral reconstruction for US.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Prevalence of depressive symptoms on postoperative day 7
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 presence of depressive symptoms.
Time frame: On postoperative day 7.
Incidence of moderate-to-severe catheter-related bladder discomfort (CRBD) within 24 hours after surgery
CRBD is defined as a strong desire to urinate or discomfort in the pubic region that occurs after awakening from anesthesia. The occurrence of CRBD will be assessed at 10 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours after surgery, and twice daily during the first postoperative day (8:00-10:00 am, or 6:00-8:00 pm). The severity of CRBD is divided into four levels: 1- None, even when asked, no discomfort is reported; 2- Mild, only report discomfort during questioning; 3-Moderate, reported discomfort without inquiry, but without behavioral reactions; 4-Severe, with the patient actively reporting discomfort and behavioral reactions (observable behavioral reactions include limb movement, strong vocal reactions, or attempts to remove the catheter).
Time frame: Up to 24 hours after surgery.
Length of hospital stay after surgery
Time interval from index surgery to hospital discharge.
Time frame: Up to 30 days after surgery.
Prevalence of depressive symptoms 30 days after surgery
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 presence of depressive symptoms.
Time frame: At 30 days postoperatively.
Area under curve (AUC) of pain intensity within 48 hours after surgery
Pain intensity will be assessed at 10 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours after surgery, and twice daily during the first postoperative day (8:00-10:00 am, or 6:00-8:00 pm) using an 11-point Numeric Rating Scale (0 = no pain, 10 = the worst pain). The AUC of pain intensity is calculated by summing the trapezoidal areas under the pain intensity data points between each pair of consecutive observations within 48 hours after surgery.
Time frame: Within 48 hours after surgery.
Percentage using rescue analgesics within 48 hours after surgery
The percentage of patients requiring rescue analgesics within 48 hours after surgery.
Time frame: Within 48 hours after surgery.
Subjective sleep quality on the night of surgery and the first postoperative night
Subjective sleep quality during the previous night will be assessed the next morning (between 8:00 and 10:00 am) using an 11-point Numeric Rating Scale (0 = the best sleep, 10 = the worst sleep).
Time frame: From the night of surgery until the first night after surgery.
Prevalence of ureteral stent-related symptoms on postoperative day 7
Ureteral stent-related symptoms will be assessed on postoperative day 7 using the Brief-form Ureteral Stent Symptom Questionnaire (8 items across 4 dimensions; total scores range from 0 to 31, with higher scores indicating more severe ureteral stent-related symptoms/discomfort).
Time frame: On postoperative day 7.
Prevalence of anxiety symptoms on postoperative day 7
Anxiety symptoms will be screened using the Generalized Anxiety Disorder-7 (GAD-7; total scores range from 0 to 21, with higher scores indicating more severe anxiety). A GAD-7 score ≥5 is defined as presence of anxiety symptoms.
Time frame: On postoperative day 7.
Prevalence of anxiety symptoms 30 days after surgery
Anxiety symptoms will be screened using the Generalized Anxiety Disorder-7 (GAD-7; total scores range from 0 to 21, with higher scores indicating more severe anxiety). A GAD-7 score ≥5 is defined as presence of anxiety symptoms.
Time frame: At 30 days postoperatively.
The incidence of severe complications within 30 days after surgery
The severity of postoperative complications is assessed using the Clavien-Dindo classification system. Severe complications are defined as Clavien-Dindo grade III or greater.
Time frame: Up to 30 days after surgery.
Subjective sleep quality at 30 days after surgery
Subjective sleep quality at 30 days is assessed using the Pittsburgh Sleep Quality Index (PSQI; scores range from 0 to 21, with higher scores indicating worse sleep quality).
Time frame: At 30 days postoperatively.
Prevalence of depressive symptoms 3 months after surgery [long-term]
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 presence of depressive symptoms.
Time frame: At 3 months after surgery.
Prevalence of depressive symptoms 6 months and 1 year after surgery [long-term]
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 presence of depressive symptoms.
Time frame: At 6 months and 1 year after surgery.
Prevalence of anxiety symptoms 3 months, 6 months and 1 year after surgery [long-tem]
Anxiety symptoms will be screened using the Generalized Anxiety Disorder-7 (GAD-7; total scores range from 0 to 21, with higher scores indicating more severe anxiety). A GAD-7 score ≥5 is defined as presence of anxiety symptoms.
Time frame: At 3 months, 6 months and 1 year after surgery.
Time to hospital readmission after surgery [long-term]
Time to hospital readmission after surgery.
Time frame: Up to 1 year after surgery.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 110 non-industry phase 4 interventional studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 59. This study's planned 36 months is close to that.
Counting every sponsor, half of 119 studies reached it within 32 months; a quarter within 17 and three quarters within 59.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: start Aug 2026 → Nov 2026, primary completion Jul 2029 → Nov 2029 and completion Aug 2029 → Nov 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Peking University First Hospital →