UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of PVC and Sn stylet for postoperative pharyngeal pain and hoarseness.
Title of the study (Brief title)	Comparison of pharyngeal pain and hoarseness by stylet
Region	Japan

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

Objectives
Narrative objectives1	Comparison of PVC and Sn stylet for postoperative pharyngeal pain and hoarseness.
Basic objectives2	Others
Basic objectives -Others	Force on stylet extubation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of hoarseness and pharyngeal pain on next morning
Key secondary outcomes	Force on stylet extubation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) 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	Tracheal intubation with PVC stylet
Interventions/Control_2	Tracheal intubation with Sn stylet
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 and Female
Key inclusion criteria	Patients who undergo general anesthesia with tracheal intubation
Key exclusion criteria	Difficult airway emergency operation
Target sample size	60

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 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 07 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2016 Year 08 Month 10 Day
Date of closure to data entry	2016 Year 08 Month 11 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The incidence of pharyngeal pain or hoarseness was significantly smaller in Sn stylet than in PVC stylet.
Other related information	Stylet extraction force was significantly smaller in the Sn stylet than in the PVC stylet.

Management information
Registered date	2016 Year 03 Month 17 Day
Last modified on	2016 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023878