NCT02228473

Brief Summary

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 28, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

August 27, 2014

Last Update Submit

October 27, 2014

Conditions

Catheter Site DiscomfortComplicationsAnesthesiaUrinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Catheter-related bladder discomfort

    Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

    1 hour postoperatively

Secondary Outcomes (9)

  • Catheter-related bladder discomfort

    0, 6 and 24 hour postoperatively

  • Hemodynamic parameters

    0, 1, 5, 10 minute postoperatively

  • Nausea

    0, 1, 6 and 24 hour postoperatively

  • Vomiting

    0, 1, 6 and 24 hour postoperatively

  • Dry mouth

    0, 1, 6 and 24 hour postoperatively

  • +4 more secondary outcomes

Study Arms (2)

Glycopyrrolate

EXPERIMENTAL

Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.

Drug: Glycopyrrolate

Atropine

ACTIVE COMPARATOR

Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.

Drug: Atropine

Interventions

GlycopyrrolateDRUG

Glycopyrrolate will be administered.

Glycopyrrolate
AtropineDRUG

Atropine will be administered.

Atropine

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for transurethral bladder excision under general anesthesia
  • ASA I-III

You may not qualify if:

  • Foley catheter less than 18 Fr.
  • Patients with obstruction of urinary tract
  • Patients with neurogenic bladder
  • Patients with severe obesity
  • Patients with neurologic disorder
  • Patients with chronic pain
  • Patients with allergic history to atropine or glycopyrrolate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University of Hospital

Seoul, Korea, Republic of, South Korea

RECRUITING

Related Publications (1)

  • Kim HC, Lim SM, Seo H, Park HP. Effect of glycopyrrolate versus atropine coadministered with neostigmine for reversal of rocuronium on postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: a prospective randomized study. J Anesth. 2015 Dec;29(6):831-5. doi: 10.1007/s00540-015-2064-2. Epub 2015 Aug 9.

    PMID: 26254585DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

GlycopyrrolateAtropine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Hee-Pyoung Park, PhD

    Seoul National University of Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Chang Kim, MD

CONTACT

82-10-2886-2876onidori1979@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

October 28, 2014

Record last verified: 2014-08

Locations

KR(1)