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Ureteral StricturePhase 4NCT07753772

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

A Phase 4 study testing Combined dexmedetomidine-esketamine administration in people with Ureteral Stricture and Dexmedetomidine, run by Peking University First Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ureteral Stricture, Dexmedetomidine, Esketamine
What is being tested?
Combined dexmedetomidine-esketamine administration
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
658 participants
Where
1 siteChina
Study dates
Aug 2026to Aug 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD, PhD contact

8610 83572784

wangdongxin@hotmail.com

Chun-Qing Li, MD contact

8610 83575138

lichuntsing@163.com

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, 8610 83572784, wangdongxin@hotmail.com

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Combined dexmedetomidine-esketamine administration, Placebo administration
Keywords
Laparoscopic ureteral reconstruction, Dexmedetomidine, Esketamine, Depressive symptoms, Anxiety
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined dexmedetomidine-esketamine administrationDrug

    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.

  • Placebo administrationDrug

    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.

Study groups in NCT07753772
Study groupRoleWhat they receive
Combined dexmedetomidine-esketamine groupExperimentalDuring 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.
Receives: Drug: Combined dexmedetomidine-esketamine administration
Placebo groupPlacebo comparatorDuring 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.
Receives: Drug: Placebo administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: On postoperative day 7.

Secondary outcomes (3)

  1. 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, 60 minutes, 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).

    Measured: Up to 24 hours after surgery.

  2. 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.

    Measured: On postoperative day 7.

  3. 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.

    Measured: At 30 days postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
658 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753772
Sponsor's protocol ID
2026-1344
Status last verified
Aug 2026
First submitted
1 Aug 2026
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tyritzis SI, Wiklund NP. Ureteral strictures revisited...trying to see the light at the end of the tunnel: a comprehensive review. J Endourol. 2015 Feb;29(2):124-36. doi: 10.1089/end.2014.0522. Epub 2014 Oct 23.

    PubMed 25100183

  • Wolf JS Jr, Elashry OM, Clayman RV. Long-term results of endoureterotomy for benign ureteral and ureteroenteric strictures. J Urol. 1997 Sep;158(3 Pt 1):759-64. doi: 10.1097/00005392-199709000-00016.

    PubMed 9258075

  • Lucas JW, Ghiraldi E, Ellis J, Friedlander JI. Endoscopic Management of Ureteral Strictures: an Update. Curr Urol Rep. 2018 Mar 2;19(4):24. doi: 10.1007/s11934-018-0773-4.

    PubMed 29500521

  • Xi Q, Wang S, Ye Z, Liu J. Combined removal of stones with resection of concurrent pathologic ureter may be a preferred treatment for impacted ureteral stones with stricture lesions. J Endourol. 2009 Feb;23(2):243-7. doi: 10.1089/end.2008.0507.

    PubMed 19220083

  • Elbers JR, Rodriguez Socarras M, Rivas JG, Autran AM, Esperto F, Tortolero L, Carrion DM, Sancha FG. Robotic Repair of Ureteral Strictures: Techniques and Review. Curr Urol Rep. 2021 Jun 9;22(8):39. doi: 10.1007/s11934-021-01056-8.

    PubMed 34105032

  • Xu MY, Song ZY, Liang CZ. Robot-assisted repair of ureteral stricture. J Robot Surg. 2024 Sep 28;18(1):354. doi: 10.1007/s11701-024-01993-9.

    PubMed 39340614

  • Shebl MA, Toraih E, Shebl M, Tolba AM, Ahmed P, Banga HS, Orz M, Tammam M, Saadalla K, Elsayed M, Kamal M, Abdulla M, Eldessouky AI, Moustafa YT, Mohamed OA, Aiash H. Preoperative anxiety and its impact on surgical outcomes: A systematic review and meta-analysis. J Clin Transl Sci. 2025 Jan 17;9(1):e33. doi: 10.1017/cts.2025.6. eCollection 2025.

    PubMed 40052059

  • Liu Y, Wu F, Zhang X, Jiang M, Zhang Y, Wang C, Sun Y, Wang B. Associations between perioperative sleep patterns and clinical outcomes in patients with intracranial tumors: a correlation study. Front Neurol. 2023 Sep 5;14:1242360. doi: 10.3389/fneur.2023.1242360. eCollection 2023.

    PubMed 37731854

  • Qiu G, Wang P, Rao J, Qing X, Cao C, Wang D, Mei B, Zhang J, Liu H, Yang Z, Liu X. Dexmedetomidine Inhibits Paraventricular Corticotropin-releasing Hormone Neurons that Attenuate Acute Stress-induced Anxiety-like Behavior in Mice. Anesthesiology. 2024 Jun 1;140(6):1134-1152. doi: 10.1097/ALN.0000000000004982.

    PubMed 38498811

  • Wei SW, Wu L, Xiang Z, Yu EY, Du Z. Dexmedetomidine alleviates acute postoperative anxiety in rats by suppressing the NF-kB pathway. Pak J Pharm Sci. 2024 Mar;37(2):349-356.

    PubMed 38767102

  • Jin HJ, Pei L, Li YN, Zheng H, Yang S, Wan Y, Mao L, Xia YP, He QW, Li M, Yue ZY, Hu B. Alleviative effects of fluoxetine on depressive-like behaviors by epigenetic regulation of BDNF gene transcription in mouse model of post-stroke depression. Sci Rep. 2017 Nov 2;7(1):14926. doi: 10.1038/s41598-017-13929-5.

    PubMed 29097744

  • Sarkisian SA, Brillhart D. An Emergency Department Presentation of Secondary Syphilis. Mil Med. 2018 Nov 1;183(11-12):e754-e755. doi: 10.1093/milmed/usy016.

    PubMed 29547908

  • Breault MS, Orguc S, Kwon O, Kang GH, Tseng B, Schreier DR, Brown EN. Anesthetics as Treatments for Depression: Clinical Insights and Underlying Mechanisms. Annu Rev Neurosci. 2025 Jul;48(1):103-124. doi: 10.1146/annurev-neuro-112723-062031. Epub 2025 Feb 19.

    PubMed 39971384

  • Chen H, Jiang C, Zhang M, Liu M, Huang S, Xie J, Liu J. Effects of complications associated with chronic obstructive pulmonary disease on lung function and hospitalization expenses: A retrospective study. Medicine (Baltimore). 2025 May 2;104(18):e42274. doi: 10.1097/MD.0000000000042274.

    PubMed 40324270

  • Zi J, Fan Y, Dong C, Zhao Y, Li D, Tan Q. Anxiety Administrated by Dexmedetomidine to Prevent New-Onset of Postoperative Atrial Fibrillation in Patients Undergoing Off-Pump Coronary Artery Bypass Graft. Int Heart J. 2020 Mar 28;61(2):263-272. doi: 10.1536/ihj.19-132. Epub 2020 Mar 4.

    PubMed 32132317

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combined dexmedetomidine-esketamine administration in people with Ureteral Stricture and Dexmedetomidine, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD, PhD (8610 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of depressive symptoms on postoperative day 7 (time frame: On postoperative day 7.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07753772, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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