Combined Dexmedetomidine and Glycopyrrolate Therapy

Bladder Irritable Clinical Trial

Official title:

Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05013320
• Other study ID #: DEXLYCO
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I and II
• elective transurethral resection of bladder tumor under general anesthesia

Exclusion Criteria:

• arrhythmia
• bladder outflow obstruction
• overacitve bladder
• end stage renal disease
• neurogenic bladder
• morbid obesity
• psychiatric disorder

Related Conditions & MeSH terms

• Bladder Irritable

Intervention

Drug:
• Glycopyrrolate + dexmedetomidine
Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.
• Dexmedetomidine
Dexmedetomidine administration during the surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of catheter-related bladder discomfort	No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort	0 minute after entering the post-anesthetic care unit
Secondary	Emergence agitation	(1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Secondary	Delirium	(1)acute and fluctuating changes in mental status (2)inattention (3)disorganized or incoherent thinking (4)altered level of consciousness. (1),(2) and (3), (1),(2), and (4), or (1)(2)(3)and (4) are defined to have deilrium.	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Secondary	Postoperative pain	numerical rating scale (0=no pain to 10=worst pain imaginable)	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Secondary	Sedation score	(1)anxious, agitated or restless (2)cooperative, oriented and trranquil (3)responds to commands, asleep (4)brisk response to light glabellar taps or oud noise (5)sluggish response to light glabellar taps or loud noise (6)noresponse	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Secondary	Dry mouth	yes or no	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Secondary	postoperative nausea and vomiting	yes or no	0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit