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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025496
Receipt No. 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

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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
Email 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
Email kumiko-t@m2.gao.ne.jp

Sponsor
Institute Gifu Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029340

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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