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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

Tracking Information
First Submitted Date  ICMJE September 26, 2014
First Posted Date  ICMJE September 30, 2014
Results First Submitted Date  ICMJE May 2, 2016
Results First Posted Date  ICMJE September 1, 2016
Last Update Posted Date September 1, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
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).
Change History Complete list of historical versions of study NCT02252445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • 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.
  • 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.
  • Nausea [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Vomiting [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Dry Mouth [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Flushing [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Blurred Vision [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Dizziness [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • 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).
  • 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.
  • Nausea [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Vomiting [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Dry Mouth [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Flushing [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Blurred Vision [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
  • Dizziness [ Time Frame: 0, 1, 6 and 24 hour postoperatively ]
    Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
Official Title  ICMJE Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort
Brief Summary The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Catheter Site Discomfort
  • Complications
  • Anesthesia
  • Urinary Bladder Neoplasms
Intervention  ICMJE
  • Drug: Propofol
    Propofol will be administered.
  • Drug: Sevoflurane
    Sevoflurane will be administered.
Study Arms  ICMJE
  • Active Comparator: Propofol
    Propofol will be administered as the anesthetic maintenance agent.
    Intervention: Drug: Propofol
  • Experimental: Sevoflurane
    Sevoflurane will be administered as the anesthetic maintenance agent.
    Intervention: Drug: Sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2016)
82
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2014)
76
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02252445
Other Study ID Numbers  ICMJE CRBDPPFSEVO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP