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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010734
Receipt No. R000012546
Scientific Title Can neuromuscular monitoring at the adductor pollicis detect timing for safe trachealintubation in elderly patients?
Date of disclosure of the study information 2013/05/16
Last modified on 2014/10/04

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Basic information
Public title Can neuromuscular monitoring at the adductor pollicis detect timing for safe trachealintubation in elderly patients?
Acronym The dose of rocuronium for safe tracheal intubation
Scientific Title Can neuromuscular monitoring at the adductor pollicis detect timing for safe trachealintubation in elderly patients?
Scientific Title:Acronym The dose of rocuronium for safe tracheal intubation
Region
Japan

Condition
Condition Surgical patients requiring general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For safe tracheal intubation, sufficient depth of neuromuscular block of the masseter, laryngeal muscles and diaphragm is needed. The responses of the adductor pollicis muscle (APM) to the ulnar nerve stimulation are usually observed during induction of anesthesia and used to determine the timing of tracheal intubation. However, movement of the vocal cord and cough reflex are frequently seen during laryngoscopy and tracheal intubation even after obtaining complete neuromuscular block at the APM.
We will examine a correlation between the dose of rocuronium and intubating conditions and hope to contribute to safe tracheal intubation in elderly patients.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes onset time of rocuronium-induced neuromuscular block and evaluation of intubating conditions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A correlation between onset of the action of rocuronium 0.6 mg/kg and intubating conditions will be analyzed.
Interventions/Control_2 A correlation between onset of the action of rocuronium 1mg/kg and intubating conditions will be analyzed.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients having allergic factors to neuromuscular blocking agents
2) ASA risk 4 and above
3) BMI 30 and above or below 18.5
4)Patients having hepatic and renal disorders
Key exclusion criteria 1)Patients having allergic factors to neuromuscular blocking agents
2)ASA risk 4 and above
3)BMI 30 and above or below 18.5
4)Patients having hepatic and renal disorders
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satomi Yamamoto
Organization Nihon University of Medicine
Division name Department of Anesthsiology
Zip code
Address 30-1 Oyaguchi-Kmimachi Itabashi-Ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nihon University of Medicine
Division name Department of Anesthsiology
Zip code
Address 30-1 Oyaguchi-Kmimachi Itabashi-Ku Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Nihon University of Medicine department of Anesthsiology
Institute
Department

Funding Source
Organization Nihon University of Medicine department of Anesthsiology
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2013 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 16 Day
Last modified on
2014 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012546

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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