UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042917 |
|---|---|
| Receipt number | R000048993 |
| Scientific Title | A study on the effect of perioperative fresh gas flow on postoperative sore throat |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2021/01/05 19:54:08 |
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Basic information
Public title
A study on the effect of perioperative fresh gas flow on postoperative sore throat
Acronym
A study on the effect of perioperative fresh gas flow on postoperative sore throat
Scientific Title
A study on the effect of perioperative fresh gas flow on postoperative sore throat
Scientific Title:Acronym
A study on the effect of perioperative fresh gas flow on postoperative sore throat
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare whether changing perioperative fresh gas flow make a difference in postoperative sore throat.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative sore throat
Key secondary outcomes
Severity of postoperative sore throat
Incidence of cough
Incidence of hoarseness
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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Fresh gas flow 6L
Interventions/Control_2
Fresh gas flow 1.5L
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Expected operation time is 1.5h - 2.5h.
The case required throat pack insertion.
Key exclusion criteria
Patients with anticipated difficult intubation.
Patients taking analgesic drugs or steroid before the surgery.
Patients with respiratory disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Funayama |
Organization
Tokyo Medical and Dental University Dental Hospital
Division name
Dental Anesthesia
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5549
funaanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Funayama |
Organization
Tokyo Medical and Dental University Dental Hospital
Division name
Dental Anesthesia
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5549
Homepage URL
funaanph@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Dental research ethics committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
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
| 2021 | Year | 02 | Month | 15 | 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 | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048993
