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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035504
Receipt No. 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 2019/01/10

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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
Email 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
Email ha_hi_hu_he_hojo@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 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
2019 Year 01 Month 10 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040438

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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