UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010875 |
|---|---|
| Receipt number | 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 20:12:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
bglim9205@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012725
