UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010734 |
|---|---|
| Receipt number | 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 20:24:42 |
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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
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
Sponsor or person
Institute
Nihon University of Medicine department of Anesthsiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012546
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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