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Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

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ClinicalTrials.gov Identifier: NCT02252445
Recruitment Status : Completed
First Posted : September 30, 2014
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

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

Detailed Description:

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways.

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arm Intervention/treatment
Active Comparator: Propofol
Propofol will be administered as the anesthetic maintenance agent.
Drug: Propofol
Propofol will be administered.

Experimental: Sevoflurane
Sevoflurane will be administered as the anesthetic maintenance agent.
Drug: Sevoflurane
Sevoflurane 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). Patients with score >0 will be counted.


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). Patients with score >0 will be counted.

  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 propofol or sevoflurane

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): NCT02252445


Locations
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Korea, Republic of
Seolu National University of Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02252445     History of Changes
Other Study ID Numbers: CRBDPPFSEVO
First Posted: September 30, 2014    Key Record Dates
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016
Last Verified: September 2014

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation