The Effect of Nefopam on Catheter-related Bladder Discomfort

NCT ID: NCT03130010

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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Nefopam Catheter-related Bladder Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The control group

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

Group Type PLACEBO_COMPARATOR

Nefopam or saline

Intervention Type DRUG

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 group

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

Group Type ACTIVE_COMPARATOR

Nefopam or saline

Intervention Type DRUG

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.

Interventions

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Nefopam or saline

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Neurogenic bladder
2. Patients diagnosed with irritable bladder
3. study drug sensitive or contraindicated
4. Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor)
5. Patients with urethral and prostate disorders
6. Patients with previous history of myocardial infarction
7. Patients with closed angle glaucoma
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eunsu Choi, pf

Role: STUDY_CHAIR

Seoul National Univ. Bundang Hospital

Locations

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Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1604/342-006

Identifier Type: -

Identifier Source: org_study_id