NCT03130010

Brief Summary

In the present study, the investigators evaluated whether nefopam 20 mg reduce the catheter-related bladder discomfort in patients undergoing foley catheter insertion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

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

Study Start

First participant enrolled

March 31, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

April 23, 2017

Last Update Submit

April 26, 2018

Conditions

NefopamCatheter-related Bladder Discomfort

Outcome Measures

Primary Outcomes (1)

  • catheter-related bladder discomfort

    assessment of catheter-related bladder discomfort using visual analogue scale

    postoperative 1 hour

Study Arms (2)

The control group

PLACEBO COMPARATOR

One hour before the end of the operation, the control group was received 20 ml of saline.

Drug: Nefopam or saline

The Nefopam group

ACTIVE COMPARATOR

One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam.

Drug: Nefopam or saline

Interventions

Nefopam or salineDRUG

One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam and the saline and the control group was received 20 ml of saline.

The Nefopam groupThe control group

Eligibility Criteria

Age20 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to insert the catheter a new foley catheter more than 14 Fr in the operation site,
  • Adults 20 to 75years of age
  • American Society of Anesthesiologists Physical Classification 1,2 patients
  • Patients who pre-agreed to the study
  • Male patient

You may not qualify if:

  • Neurogenic bladder
  • Patients diagnosed with irritable bladder
  • study drug sensitive or contraindicated
  • Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor)
  • Patients with urethral and prostate disorders
  • Patients with previous history of myocardial infarction
  • Patients with closed angle glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

NefopamSodium Chloride

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Eunsu Choi, pf

    Seoul National Univ. Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 26, 2017

Study Start

March 31, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 30, 2018

Record last verified: 2017-04

Locations

KR(1)