UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014897 |
|---|---|
| Receipt number | R000017286 |
| Scientific Title | Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients : A prospective randomized controlled trial |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2014/10/31 14:26:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients : A prospective randomized controlled trial
Acronym
Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients
Scientific Title
Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients : A prospective randomized controlled trial
Scientific Title:Acronym
Effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of muscle relaxant for laryngeal mask ProSeal® insertion efficacy in anesthetized patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ventilation success, sealing pressure
Key secondary outcomes
Pharyngealpain, hoarseness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Rocronium administration
Interventions/Control_2
No rocronium administration
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
Patients who underwentgeneral anesthesia
Key exclusion criteria
Patients who are contraindicated for SGD use.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Nishihara |
Organization
Hokusetsu General Hospital
Division name
Anesthesiology
Zip code
Address
6-24, Kitayanagawa, Takatsuki, Osaka
TEL
072-696-2121
xn6i-nshr@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
072-696-2121
Homepage URL
koma21century@yahoo.co.jp
Sponsor or person
Institute
Hokusetsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka MedicalCollege
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
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
| 2014 | Year | 09 | Month | 01 | 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
Sealing pressure and insertion success rate was significantly higher in muscle relaxant groups.
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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 19 | Day |
Last modified on
| 2014 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017286
