UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035504 |
|---|---|
| Receipt number | R000040438 |
| Scientific Title | Is muscle relaxant useful to facilitate insertion of LMA-Supreme: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2019/12/17 10:24:53 |
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Basic information
Public title
Is muscle relaxant useful to facilitate insertion of LMA-Supreme: a prospective randomized controlled trial
Acronym
Is muscle relaxant useful to facilitate insertion of LMA-Supreme: a prospective randomized controlled trial
Scientific Title
Is muscle relaxant useful to facilitate insertion of LMA-Supreme: a prospective randomized controlled trial
Scientific Title:Acronym
Is muscle relaxant useful to facilitate insertion of LMA-Supreme: a prospective randomized controlled trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed at determining whether muscle relaxants facilitates insertion efficacy of the LMA-Supreme by novice doctors in anesthetized patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the proportion of first attempt to successful insertion
Key secondary outcomes
sealing pressure, the number of attempts required for successful insertion, the incidence of sore throat and hoarseness one day after surgery,subjective difficulty of insertion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Routine monitoring of electrocardiography, non-invasive blood pressure, pulse oximetry, and end-tidal carbon dioxide tension was performed. All patients are preoxygenated for 3 min with a total flow adjusted to 6 L/min. Anesthesia is induced with propofol 2.5mg/kg and fentanyl one microgram/kg. After loss of consciousness, rocuronium 0.3mg/kg is administered, and mask ventilation was performed with 5% sevoflurane for 90 seconds. SLMA is inserted 90 seconds after rocuronium administration. The SLMA is inserted and fixed according to the manufacturer's instructions. The size of SLMA is chosen based on the patient's body weight according to the manufacturer's instructions. Junior residents insert the SLMA. Intracuff pressure is adjusted to 60cmH2O using a cuff pressure monitor. Successful insertion is confirmed based on bilateral chest wall movement, normal capnograph curves, and sealing pressure of 15 cmH2O or over. If the third attempt is failed, this is recorded as a failure. At the end of insertion, the residents rate the difficulty using a visual analog scale, which ranges from 0mm (extremely easy) to 10mm (extremely difficult).
Interventions/Control_2
Routine monitoring of electrocardiography, non-invasive blood pressure, pulse oximetry, and end-tidal carbon dioxide tension was performed. All patients are preoxygenated for 3 min with a total flow adjusted to 6 L/min. Anesthesia is induced with propofol 2.5mg/kg and fentanyl one microgram/kg. After loss of consciousness, normal saline 0.03ml/kg is administered, and mask ventilation was performed with 5% sevoflurane for 90 seconds. SLMA is inserted 90 seconds after normal saline administration. The SLMA is inserted and fixed according to the manufacturer's instructions. The size of SLMA is chosen based on the patient's body weight according to the manufacturer's instructions. Junior residents insert the SLMA. Intracuff pressure is adjusted to 60cmH2O using a cuff pressure monitor. Successful insertion is confirmed based on bilateral chest wall movement, normal capnograph curves, and sealing pressure of 15 cmH2O or over. If the third attempt is failed, this is recorded as a failure. At the end of insertion, the residents rate the difficulty using a visual analog scale, which ranges from 0mm (extremely easy) to 10mm (extremely difficult).
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
Female
Key inclusion criteria
the patiens who are going to have an elective mastectomy
Key exclusion criteria
any contraindication for the use of LMA, allergy to medication to be used during anesthesia, mouse opening <2.5cm, BMI>30, ASA-PS>3
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaya Hojo |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anaesthesia
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
ha_hi_hu_he_hojo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Hojo |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anaesthesia
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
ha_hi_hu_he_hojo@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan
Organization
Division
Category of Funding Organization
Local Government
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
東京都立多摩総合医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 10 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 08 | 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
| 2019 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040438
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