UMIN-CTR Clinical Trial

Basic information
Public title	The effect of reducing postoperative sore throat by zinc troche before surgery in general anesthesia with tracheal intubation in the beach chair position
Acronym	The effect of reducing postoperative sore throat by zinc troche before surgery in general anesthesia with tracheal intubation in the beach chair position
Scientific Title	The effect of reducing postoperative sore throat by zinc troche before surgery in general anesthesia with tracheal intubation in the beach chair position
Scientific Title:Acronym	The effect of reducing postoperative sore throat by zinc troche before surgery in general anesthesia with tracheal intubation in the beach chair position
Region	Japan

Condition
Condition	Sore throat after tracheal intubation
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Postoperative sore throat occurs in 14.5-50% of patients with tracheal intubation. In recent years, zinc has been reported to be effective against oral disorders such as mouth ulcer caused by radiation therapy and chemotherapy. Hypothesize and test that zinc troches are effective for postoperative sore throat due to tracheal intubation in beach chairs
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of sore throat Degree of sore throat
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Zinc-containing candy administered 30 minutes before anesthesia
Interventions/Control_2	Zinc-free candy administration 30 minutes before anesthesia
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	18 years old and over ASA1-2 Those who undergo tracheal intubation in the beach chair position
Key exclusion criteria	Preoperative sore throat Upper respiratory tract inflammation Immunodeficiency Chronic smoker History of head and neck surgery History of intubation difficulty Use of tetracycline or quinolone antibiotics Zinc allergy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Kotera
Organization	Osaka orthopedic Hospital
Division name	department of anesthesiology
Zip code	553-0007
Address	Obiraki,Hukusimaku,Osaka
TEL	0664631111
Email	starbucks.tomo@gmail.com

Public contact
Name of contact person	1st name Tomoko Middle name Last name Kotera
Organization	Osaka orthopedic Hospital
Division name	department of anesthesiology
Zip code	553-0007
Address	Obiraki,Hukusimaku,Osaka
TEL	0664631111
Homepage URL
Email	starbucks.tomo@gmail.com

Sponsor
Institute	Osaka orthopedic Hospital
Institute
Department

Funding Source
Organization	Osaka orthopedic Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka orthopedic Hospital
Address	Obiraki,Hukusimaku,Osaka
Tel	0664631111
Email	starbucks.tomo@gmail.com

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	大阪整形外科病院　(大阪府)

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 11 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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 11 Month 12 Day
Last follow-up date	2022 Year 05 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	2021 Year 11 Month 10 Day
Last modified on	2021 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052493