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

NCT06399185 Phase 4 RECRUITING

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.

Details

Lead sponsor	Peking University First Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	1740
Start date	2024-06-06
Completion	2027-05

Conditions

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

Interventions

• Normal saline
• Dexmedetomidine
• Esketamine
• Combined dexmedetomidine-esketamine

Primary outcomes

• Incidence of catheter-related bladder discomfort (CRBD) within 24 hours after surgery. — Up to 24 hours after surgery.
  Defined as occurrence of moderate or severe CRBD at any time point within 24 hours after surgery. CRBD is a strong desire to urinate or discomfort in the pubic region that occurs after awakening from anesthesia. The occurrence of CRBD is assessed at 0 hour (arriving post-anesthesia care unit), 1 hour, 2 hours, 6 hours, and 24 hours after surgery. 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).

Countries

China