UMIN-CTR Clinical Trial

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