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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010875
Receipt No. R000012725
Scientific Title The effects of nefopam on remifentanil-induced pronociceptive effect in middle ear surgery
Date of disclosure of the study information 2013/06/04
Last modified on 2015/02/22

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Basic information
Public title The effects of nefopam on remifentanil-induced pronociceptive effect in middle ear surgery
Acronym The effects of nefopam on remifentanil-induced hyperalgesia
Scientific Title The effects of nefopam on remifentanil-induced pronociceptive effect in middle ear surgery
Scientific Title:Acronym The effects of nefopam on remifentanil-induced hyperalgesia
Region
Asia(except Japan)

Condition
Condition middle ear surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Remifentanil can cause acute opioid tolerance/hyperalgesia due to central sensitization by the activation of N-methyl-D-aspartate (NMDA) receptors, resulting in increased early postoperative pain. Therefore, we will investigate the effects of continuous infusion of nefopam, a NMDA receptor antagonist, on early postoperative pain/analgesic requirement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Recovery profiles, visual analogue scale (VAS) for pain scores, time to first analgesic requirement/analgesic demand
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Control group will be infused with an equal amount of normal saline for 20 min with remifentanil infusion of 0.1 mcg/kg/min
Interventions/Control_2 Nefopam 40 mg mixed to normal saline 100 mL will be slowly administrated throughout 20 min with remifentanil infusion of 0.1 mcg/kg/min in nefopam group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
25 years-old <
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Patients aged 25-65 years with American Society of Anesthesiologists physical status of 1 or 2 who are scheduled to undergo elective middle ear surgery.
Key exclusion criteria Patients with a history of drug abuse, renal or hepatic diseases and those taking analgesics will be excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Byung Gun Lim
Organization Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82-2-2626-1437
Email bglim9205@korea.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Byung Gun Lim
Organization Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82-2-2626-1437
Homepage URL
Email bglim9205@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

Funding Source
Organization Korea University
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Korea University Guro Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The analgesic effect of nefopam combined with low dose remifentanil in patients undergoing middle ear surgery under desflurane anesthesia: a randomized controlled trial.


Yoo JY, Lim BG, Kim H, Kong MH, Lee IO, Kim NS.

Korean J Anesthesiol. 2015 Feb;68(1):43-9. doi: 10.4097/kjae.2015.68.1.43. Epub 2015 Jan 28.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
2013 Year 08 Month 16 Day
Date trial data considered complete
2013 Year 08 Month 19 Day
Date analysis concluded
2013 Year 08 Month 23 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 04 Day
Last modified on
2015 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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