UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Title of the study (Brief title)	i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Region	Japan

Condition
Condition	Patients who undergo general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of i-gel3 and i-gel 4 for effective airway management during general anesthesia in patients 50-60kg.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sealing pressure
Key secondary outcomes	insertion time insertion number postoperative pharygeal pain hoarseness relative position of glottis and i-ge

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	application of i-gel3 to i-gel4
Interventions/Control_2	application of i-gel4 to -gel3
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing general anesthesia with SGD
Key exclusion criteria	Patients who is contraindicated for SGD usage.
Target sample size	40

Research contact person
Name of lead principal investigator	Toshiaki Minami
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7 Daigaku-machi, Takatsuk city
TEL	0726-84-6361
Email	ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person	Nobuyasu Komasawa
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7Daigaku-machi, Takatsuki city
TEL	0726-84-6361
Homepage URL
Email	ane078@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical college
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 04 Day
Anticipated trial start date	2016 Year 07 Month 10 Day
Last follow-up date	2016 Year 10 Month 08 Day
Date of closure to data entry	2016 Year 10 Month 11 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Sealing pressure was higher in size3 than size 4. Insertion time was smaller in size3 than size4. Insertion number was smaller in size than size 4.
Other related information	Abnormality of relative position to the glottis was higher in size4 than in size3.

Management information
Registered date	2016 Year 07 Month 04 Day
Last modified on	2016 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024999