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WithdrawnNCT05013320Updated Aug 19, 2021

Combined Dexmedetomidine and Glycopyrrolate Therapy

An interventional study of Glycopyrrolate + dexmedetomidine and Dexmedetomidine in Bladder Irritable, sponsored by Kangbuk Samsung Hospital. Withdrawn. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-08-19.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Prevention

Why this study was withdrawn
We could not get the IRB approval
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Irritable
03

In context

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • arrhythmia
  • bladder outflow obstruction
  • overacitve bladder
  • end stage renal disease
  • neurogenic bladder
  • morbid obesity
  • psychiatric disorder
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Dexmedetomidine only

    dexmedetomidine is administered during the surgery

    Drug: Dexmedetomidine

  • Experimental
    Combined dexmedetomidine and glycopyrrolate

    glycopyrrolate and dexmedetomidine are administered during the surgery

    Drug: Glycopyrrolate + dexmedetomidine

Interventions

  • DrugGlycopyrrolate + dexmedetomidine

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

  • DrugDexmedetomidine

    Dexmedetomidine administration during the surgery.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0 minute after entering the post-anesthetic care unit

Secondary outcomes

  1. Emergence agitation

    (1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable

    Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

  2. 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.

    Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

  3. Postoperative pain

    numerical rating scale (0=no pain to 10=worst pain imaginable)

    Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

  4. 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

    Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

  5. Dry mouth

    yes or no

    Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

  6. postoperative nausea and vomiting

    yes or no

    Time frame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05013320
Lead sponsor
Kangbuk Samsung Hospital
Responsible party
Eunah Cho, MD (Assistant professor, Kangbuk Samsung Hospital) — Principal investigator
First posted
Aug 19, 2021
Start date
Sep 1, 2021 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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