UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025496 |
|---|---|
| Receipt number | R000029340 |
| Scientific Title | Effect of the degree of neuromuscular blockade on surgical condition and postoperative pain after intraoral surgery |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2019/06/12 13:15:25 |
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Basic information
Public title
Effect of the degree of neuromuscular blockade on surgical condition and postoperative pain after intraoral surgery
Acronym
neuromuscular blockade and intraoral surgery
Scientific Title
Effect of the degree of neuromuscular blockade on surgical condition and postoperative pain after intraoral surgery
Scientific Title:Acronym
neuromuscular blockade and intraoral surgery
Region
| Japan |
Condition
Condition
intraoral surgery under general anesthesia
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The impact of neuromuscular blockade on surgical space condition and postoperative pain of temporomandibular joint or the other sites
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
condition of surgical space,
on the day of surgery and the next day, postoperative pain of temporomandibular joint or the other sites
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After intratracheal intubation with neuromuscular blockade, neuromuscular blockade is continuously infused targeting train of four 0/4.
Interventions/Control_2
After intratracheal intubation with neuromuscular blockade, neuromuscular blockade in not used.
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo intraoral surgery under general anesthesia
Key exclusion criteria
Patient who can not obtain consent and is difficult to evaluate pain intensity.
Patient who is expected to have difficulty in endotracheal intubation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City Yanagido 1-1
TEL
058-230-6404
kumiko-t@m2.gao.ne.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City Yanagido 1-1
TEL
058-230-6404
Homepage URL
kumiko-t@m2.gao.ne.jp
Sponsor or person
Institute
Gifu Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Graduate School of Medicine
Address
Yanagido 1-1, Gifu city
Tel
058-230-6059
gjme00004@jim.gifu-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
45
Results
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
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029340
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
