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Combined Dexmedetomidine and Glycopyrrolate Therapy

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05013320
Enrollment
0
Registered
2021-08-19
Start date
2021-09-01
Completion date
2022-12-31
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Irritable

Brief 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.

Interventions

DRUGGlycopyrrolate + dexmedetomidine

Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.

DRUGDexmedetomidine

Dexmedetomidine administration during the surgery.

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of catheter-related bladder discomfort0 minute after entering the post-anesthetic care unitNo = 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

Secondary

MeasureTime frameDescription
Delirium0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit(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.
Postoperative pain0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unitnumerical rating scale (0=no pain to 10=worst pain imaginable)
Emergence agitation0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit(1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable
Dry mouth0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unityes or no
postoperative nausea and vomiting0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unityes or no
Sedation score0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit(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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026