UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046029 |
|---|---|
| Receipt number | R000052493 |
| 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 |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2021/11/10 17:03:45 |
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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
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
starbucks.tomo@gmail.com
Sponsor or person
Institute
Osaka orthopedic Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052493
