NCT02096224

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 2, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 21, 2014

Last Update Submit

September 30, 2014

Conditions

Catheter Site DiscomfortComplicationsAnesthesiaUrinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Catheter-related bladder discomfort

    Catheter-related bladder discomfort will be measured for 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

    24 hour postoperatively

Secondary Outcomes (4)

  • Catheter-related bladder discomfort

    0, 1, 6 and 24 hour postoperatively

  • Nausea

    0, 1, 6 and 24 hour postoperatively

  • Vomiting

    0, 1, 6 and 24 hour postoperatively

  • Dry mouth

    0 houe after admission of operating room

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Sevoflurane will be administered as the maintenance agent of general anesthesia.

Drug: Sevoflurane

Desflurane

ACTIVE COMPARATOR

Desflurane will be administered as the maintenance agent of general anesthesia.

Drug: Desflurane

Interventions

SevofluraneDRUG

Sevoflurane will be used.

Sevoflurane
DesfluraneDRUG

Desflurane will be used

Desflurane

Eligibility Criteria

Age18 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:

  • Bladder outflow obstruction
  • Overactive bladder
  • End-stage renal disease
  • Neurogenic bladder
  • Heart failure
  • Arrhythmia
  • Morbid obesity
  • Use of chronic analgesic medication
  • Hepatic disease
  • Pulmonary disease
  • Psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University of Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim HC, Hong WP, Lim YJ, Park HP. The effect of sevoflurane versus desflurane on postoperative catheter-related bladder discomfort in patients undergoing transurethral excision of a bladder tumour: a randomized controlled trial. Can J Anaesth. 2016 May;63(5):596-602. doi: 10.1007/s12630-016-0600-7. Epub 2016 Feb 1.

    PMID: 26830645DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

SevofluraneDesflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Hee-Pyoung Park, PhD

    Seoul National University of Hospital

    STUDY CHAIR

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

March 21, 2014

First Posted

March 26, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 2, 2014

Record last verified: 2014-03

Locations

KR(1)