Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399185
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-30
Brief Title:
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort in Patients Undergoing Transurethral Surgery a 2 x 2 Factorial Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 03-10 μgkg 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 025 mgkg or 05 mgkg 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
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 03-10 μgkg 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 025 mgkg or 05 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None