NCT05013320

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

May 13, 2021

Last Update Submit

August 17, 2021

Conditions

Bladder Irritable

Outcome Measures

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

    0 minute after entering the post-anesthetic care unit

Secondary Outcomes (6)

  • Emergence agitation

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

  • Delirium

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

  • Postoperative pain

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

  • Sedation score

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

  • Dry mouth

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

  • +1 more secondary outcomes

Study Arms (2)

Dexmedetomidine only

ACTIVE COMPARATOR

dexmedetomidine is administered during the surgery

Drug: Dexmedetomidine

Combined dexmedetomidine and glycopyrrolate

EXPERIMENTAL

glycopyrrolate and dexmedetomidine are administered during the surgery

Drug: Glycopyrrolate + dexmedetomidine

Interventions

Glycopyrrolate + dexmedetomidineDRUG

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

Combined dexmedetomidine and glycopyrrolate
DexmedetomidineDRUG

Dexmedetomidine administration during the surgery.

Dexmedetomidine only

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

GlycopyrrolateDexmedetomidine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 13, 2021

First Posted

August 19, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 19, 2021

Record last verified: 2021-08