NCT06399185

Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,740 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Catheter-related bladder discomfort (CRBD) is common in patients awaking from general anesthesia with an urinary catheter. We suppose that that use of dexmedetomidine and/or esketamine during anesthesia may reduce the occurrence of CRBD. This 2x2 factorial randomized trial is designed to explore the effects of esketamine, dexmedetomidine, and their combination on the occurrence CRBD in patients undergoing transurethral urological surgery.

Detailed description

Urethral catheterization is commonly used during and after surgery. However, patients with indwelling urinary catheters often present with catheter-related bladder discomfort (CRBD) after awakening from anesthesia. CRBD is characterized by pain and discomfort in the suprapubic area or symptoms like overactive bladder, characterized by frequent and urgent urination, with or without acute incontinence. The incidence of CRBD is relatively high, ranging from 47% to 90%. The development of CRBD not only reduces patients' perioperative satisfaction, but also increases the incidence of postoperative complications, affects patients' postoperative rehabilitation, and prolongs the length of hospital stay. It also increases the workload of medical staff. The occurrence of CRBD is affected by many factors, such as gender, size of urinary tube, and type of surgery. Studies show that the use of ≥18F catheter increases the incidence of CRBD. After transurethral surgery, such as transurethral resection of bladder tumor (TUR-Bt), transurethral resection of prostate (TURP), and transurethral holmium laser resection of prostate (HoLRP), a 20F catheter is often required for bladder irrigation; the catheter carrying time may be extended for bladder perfusion. Therefore, the incidence of CRBD is higher after such operations. Dexmedetomidine is a highly selective α2 receptor agonist with analgesic, anxiolytic, and sedative effects. Several randomized trial confirmed that intraoperative use of 0.3-1.0 μg/kg dexmedetomidine reduces the incidence and severity of postoperative CRBD, and the effect persists up to 6 hours after surgery. Ketamine is a non-competitive N-methyl-D-aspartate receptor antagonist and produces analgesic and anti-hyperalgesia effects. A recent meta-analysis found that subanesthetic doses of ketamine (0.25 mg/kg or 0.5 mg/kg) reduce the severity of CRBD within 1-2 hours after surgery and the incidence of CRBD within 2-6 hours after surgery. Esketamine is the S-enantiomer of racemic ketamine and has a higher affinity for NMDA receptors; it is twice as potent as racemic ketamine. The investigators hypothesize that the combination of dexmedetomidine and esketamine may improve the efficacy in preventing CRBD. This 2x2 factorial trial is designed to observe the effect of dexmedetomidine, esketamine, and dexmedetomidine-esketamine combination on the occurrence of CRBD in patients following transurethral urological surgery.

Conditions

• Urinary Catheter
• Catheter-related Bladder Discomfort
• Dexmedetomidine
• Esketamine

Interventions

Type	Name	Description
DRUG	Normal saline	20 ml of normal saline is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
DRUG	Dexmedetomidine	Dexmedetomidine 0.5 μg/kg, diluted with normal salinet o 20 ml, is infused intravenously at 60 ml/h after anesthesia induction but before surgery.
DRUG	Esketamine	Esketamine 0.25 mg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.
DRUG	Combined dexmedetomidine-esketamine	Dexmedetomidine 0.5 μg/kg and esketamine 0.25 mg/kg, diluted with normal saline to 20 ml, is infused intravenously at 80 ml/h after anesthesia induction but before surgery.

Timeline

• Start date: 2024-06-06
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2024-05-03
• Last updated: 2025-07-31

Locations

2 sites across 1 country: China