Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

NCT02252445 | Completed Results DMC

• 1 other identifier: CRBDPPFSEVO
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Catheter Site Discomfort; Complications; Anesthesia; Urinary 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). Patients with score \>0 will be counted.

  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

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Propofol will be administered as the anesthetic maintenance agent.

Drug: Propofol

Sevoflurane

EXPERIMENTAL

Sevoflurane will be administered as the anesthetic maintenance agent.

Drug: Sevoflurane

Interventions

Propofol DRUG

Propofol will be administered.

Propofol

Sevoflurane DRUG

Sevoflurane will be administered.

Sevoflurane

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 propofol or sevoflurane

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seolu National University of Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Assistant professor
• Organization: Keimyung university

onidori1979@gmail.com

+821028862876

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 26, 2014
• First Posted: September 30, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 1, 2016
• Results First Posted: September 1, 2016

Record last verified: 2014-09

Locations

KR (1)