UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.
Title of the study (Brief title)	Investigation of the effect of lubrication with KY jelly on the increase in the cuff pressure of endotracheal tube during general anesthesia using nitrous oxide.
Region	Japan

Condition
Condition	The patients (ASA physical status 1 or 2), aged 20 to 80, scheduled for elective surgery under general anaesthesia requiring tracheal intubation.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the cuff pressure behaviors of the endotracheal tube in the presence of lubrication with those in the absence of lubrication during general anesthesia using nitrous oxide.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of lubrication with KY jelly on the cuff pressure behaviors of the endotracheal tube during nitrous oxide exposure.
Key secondary outcomes	Sore throat and hoarseness after extubation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Endotracheal tube with lubrication with 3 g of KY jelly.
Interventions/Control_2	Endotracheal tube without any lubrication.
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	The patients (ASA physical status 1 or 2), aged 20 to 80, scheduled for elective surgery under general anaesthesia requiring tracheal intubation.
Key exclusion criteria	ASA physical status more than 3, the history of PONV, laparoscopic surgery, the surgery in the prone position, major cardiovascular surgery, thoracic surgery, morbidly obese subjects (BMI>35), anticipated difficult intubation or the history of difficult intubation and the subjects in whom the use of nitrous oxide is considered inappropriate.
Target sample size	50

Research contact person
Name of lead principal investigator	Yukihide Koyama
Organization	Mizonokuchi Hospital, Teikyo University School of Medicine
Division name	Anesthesiology
Address	5-1-1, Futako, Takatsu-ku, Kawasaki, Kanagawa, Japan
TEL	044-844-3333
Email	yukihidekoyama1008@gmail.com

Public contact
Name of contact person	Yukihide Koyama
Organization	Mizonokuchi Hospital, Teikyo University School of Medicine
Division name	Anesthesiology
Address	5-1-1, Futako, Takatsu-ku, Kawasaki, Kanagawa, Japan
TEL	044-844-3333
Homepage URL
Email	yukihidekoyama1008@gmail.com

Sponsor
Institute	Department of Anesthesiology, Tomei Atsugi Hospital, Atsugi, Japan
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Tomei Atsugi Hospital, Atsugi, Japan
Organization
Division
Category of Funding Organization	Other
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	東名厚木病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded	2019 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 20 Day
Last modified on	2018 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035831