UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009385 |
|---|---|
| Receipt number | R000008103 |
| Scientific Title | Radamized controlled trial ofremifentanil and propofol for nasotrachealintubation condition without the use of muscle relaxants |
| Date of disclosure of the study information | 2012/12/27 |
| Last modified on | 2012/11/22 16:45:14 |
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Basic information
Public title
Radamized controlled trial ofremifentanil and propofol for nasotrachealintubation condition without the use of muscle
relaxants
Acronym
Study of remifentanil and propofol for nasotrachealintubation without the use
of muscle relaxants
Scientific Title
Radamized controlled trial ofremifentanil and propofol for nasotrachealintubation condition without the use of muscle
relaxants
Scientific Title:Acronym
Study of remifentanil and propofol for nasotrachealintubation without the use
of muscle relaxants
Region
| Japan |
Condition
Condition
Patients of nasotracheal intubation for general anesthesia.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The necessity of neuromuscular blocking drug for nasotracheal intubation case when Remifentanil and propofol anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It classifies according to three steps for difficulty of laryngoscopy, state of vocal cords during intubation and body movement when intubation and cuff infration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remifentanil 0.5microg/kg/min and Propofol0.5mg/kg is prescribed for the patient, and anesthesia induction is carried out by propofol 5.0mg/kg/h after that. An isotonic sodium chloride solution is prescribed for the patient, and nasal intubation is carried out 10 minutes after a remifentanil start. The isotonic sodium chloride solution medication which is equivalent to sugamadex 2mg/kg at the time of the end of an operation is prescribed for the patient.
Interventions/Control_2
Introductory
Remifentanil 0.5microg/kg/min and Propofol0.5mg/kg is prescribed for the patient, and anesthesia induction is carried out by propofol 5.0mg/kg/h after that.
Rocuronium 0.6mg/ kg medication is carried out, and nasal intubation is carried out 10 minutes after a remifentanil start. Sugamadex2mg/kg is prescribed for the patient at the time of the end of an operation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who had exodontia, a jaw cyst extirpation, and orthognathic surgery planned under general anesthesia.
Key exclusion criteria
BMI score are 25 or more patients.
They are three or more patients in Mallampati score.
The amount of openings is a patient of less than 3.5 cm.
A patient who has a cervical vertebrae disease.
They are three or more patients in Cormack and Lehane score.
A patient who has two or more cardiopathy by the heartbeat classification of NYHA.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sunada |
Organization
The Nippon Dental University school of Life Dentistry at Tokyo
Division name
Department of Dental Anesthesiology The Nippon Dental University school of Life Dentistry at Tokyo
Zip code
Address
1-9-20Fujimi,Chiyoda-ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Nippon Dental University school of Life Dentistry at Tokyo
Division name
Department of Dental Anesthesiology The Nippon Dental University school of Life Dentistry at Tokyo
Zip code
Address
1-9-20Fujimi,Chiyoda-ku,Tokyo
TEL
Homepage URL
Sponsor or person
Institute
The Nippon Dental University school of Life Dentistry at Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University school of Life Dentistry at Tokyo
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 12 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 22 | 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
| 2012 | Year | 11 | Month | 22 | Day |
Last modified on
| 2012 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008103
