Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06399185

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort in Patients Undergoing Transurethral Surgery: a 2 x 2 Factorial Randomized Trial

Led by Peking University First Hospital · Updated on 2025-07-31

1740

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

P

Peking University First Hospital

Lead Sponsor

P

Peking University Shenzhen Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Catheter-related bladder discomfort (CRBD) is a common issue for patients waking up from general anesthesia with a urinary catheter, especially after transurethral urological surgeries. This trial explores how dexmedetomidine, esketamine, and their combination may affect the occurrence of CRBD. The study is designed as a 2x2 factorial randomized trial to observe these effects in patients undergoing surgeries like transurethral resection of bladder tumor or prostate. Participants are randomly assigned to one of four groups: a placebo group receiving normal saline, a dexmedetomidine group receiving 0.5 bcg/kg, an esketamine group receiving 0.25 mg/kg, or a combination group receiving both drugs. Each treatment is infused intravenously at a set rate after anesthesia induction but before surgery. The trial uses triple masking and aims to compare the incidence of CRBD among these groups. During the study, participants will be monitored for CRBD incidence and severity within 24 hours after surgery, along with pain intensity, sleep quality, patient satisfaction, anxiety, and depression at various time points. Assessments include subjective sleep quality on the night of surgery and follow-up evaluations up to 30 days after surgery. The study tracks these outcomes to understand how the treatments influence CRBD and related post-surgical recovery factors.

CONDITIONS

Brief Title

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or above
  • Scheduled for transurethral bladder or prostate surgery under general anesthesia
  • Required postoperative retention of a three-chamber urinary catheter
Not Eligible

You will not qualify if you...

  • Indwelling urinary catheters or chronic analgesic therapy for 531 month before surgery
  • Uncontrolled hypertension before surgery (resting ward systolic pressure >180 mmHg or diastolic pressure >110 mmHg)
  • Severe bradycardia (heart rate 50450 beats per minute), sick sinus syndrome, or atrioventricular block of degree II or above without pacemaker
  • History of myocardial infarction, severe heart insufficiency (NYHA class 543), or tachyarrhythmia within a year
  • Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension
  • Preoperative history of hyperthyroidism and pheochromocytoma
  • Inability to communicate due to coma, severe dementia, or language barrier before surgery
  • Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (receiving dialysis before surgery), or ASA classification 544
  • Scheduled admission to ICU with endotracheal intubation after surgery
  • Other conditions considered unsuitable for study participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During surgery and immediately before

Participants receive an intravenous infusion of dexmedetomidine, esketamine, their combination, or normal saline after anesthesia induction but before surgery to prevent catheter-related bladder discomfort.

1 treatment visit (in-hospital)

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for catheter-related bladder discomfort and other outcomes up to 30 days after surgery.

Multiple visits including assessments at 6 hours, the morning after surgery, hospital discharge or 2 days after surgery, and 30 days after surgery

Trial Site Locations

Total: 2 locations

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

2

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

R

Rui Zhang, MD

L

Li Huaijin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

A randomised-controlled, prospective study on the effect of dorsal penile nerve block after TURP on catheter-related bladder discomfort and pain.

Yunus Emre Göger, Mehmet Serkan Özkent, Esra Göger...

https://pubmed.ncbi.nlm.nih.gov/33368991

Effect of Pudendal Nerve Block on the Prevention of Postoperative Bladder Spasm and Catheter-Related Bladder Discomfort in Male Patients Undergoing Transurethral Holmium Laser Enucleation of the Prostate.

Sheng-Yan Wang, Qing Qiu, Xu Shen

https://pubmed.ncbi.nlm.nih.gov/36474581

Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study.

A Agarwal, G Yadav, D Gupta...

https://pubmed.ncbi.nlm.nih.gov/18653496

The efficacy and safety of antimuscarinics for the prevention or treatment of catheter-related bladder discomfort: a systematic review and meta-analysis of randomized controlled trials.

Zhongbao Zhou, Yuanshan Cui, Xiaoyi Zhang...

https://pubmed.ncbi.nlm.nih.gov/34903279