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Trial record 6 of 185 for:    GLYCOPYRROLATE

Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02228473
Recruitment Status : Unknown
Verified August 2014 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 29, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Catheter Site Discomfort Complications Anesthesia Urinary Bladder Neoplasms Drug: Glycopyrrolate Drug: Atropine Not Applicable

Detailed Description:

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. The adjuncts to reversal agents such as glycopyrrolate and atropine are known to block the muscarinic receptor in different ways.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort
Study Start Date : September 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : March 2015

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Arm Intervention/treatment
Experimental: Glycopyrrolate
Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.
Drug: Glycopyrrolate
Glycopyrrolate will be administered.

Active Comparator: Atropine
Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.
Drug: Atropine
Atropine will be administered.




Primary Outcome Measures :
  1. Catheter-related bladder discomfort [ Time Frame: 1 hour postoperatively ]
    Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).


Secondary Outcome Measures :
  1. Catheter-related bladder discomfort [ Time Frame: 0, 6 and 24 hour postoperatively ]
    Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

  2. Hemodynamic parameters [ Time Frame: 0, 1, 5, 10 minute postoperatively ]
    Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.

  3. Nausea [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.

  4. Vomiting [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

  5. Dry mouth [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.

  6. Flushing [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.

  7. Blurred vision [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.

  8. Dizziness [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.

  9. Analgesics [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228473


Contacts
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Contact: Hyun-Chang Kim, MD 82-10-2886-2876 onidori1979@gmail.com

Locations
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Korea, Republic of
Seoul National University of Hospital Recruiting
Seoul, Korea, Republic of, Korea, Republic of
Contact: Hee-Pyoung Park, PhD    +82-10-2971-7647    hppark@snu.ac.kr   
Principal Investigator: Hyun-Chang Kim, MD         
Principal Investigator: Hee-Pyoung Park, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Pyoung Park, PhD Seoul National University of Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02228473     History of Changes
Other Study ID Numbers: CRBDGlycoAtr
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Glycopyrrolate
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action