UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047798 |
|---|---|
| Receipt number | R000054492 |
| Scientific Title | Randomized controlled trials for dry mouth after general anesthesia |
| Date of disclosure of the study information | 2022/05/18 |
| Last modified on | 2022/05/19 12:27:47 |
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Basic information
Public title
Randomized controlled trials for dry mouth after general anesthesia
Acronym
Intraoperative sealing test for dry mouth after anesthesia
Scientific Title
Randomized controlled trials for dry mouth after general anesthesia
Scientific Title:Acronym
Intraoperative sealing test for dry mouth after anesthesia
Region
| Japan |
Condition
Condition
Scheduled general anesthesia management patients (excluding prone position cases)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with general anesthesia are randomly assigned to the sealing group and the non-sealing group, and it is investigated whether there is a difference in thirst, hoarseness, and sore throat after general anesthesia.
The day after surgery, we interview with the patient the degree of dry mouth evaluate using a numerical evaluation scale of 0-10.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ask the patient to evaluate the feeling of dry mouth immediately after general anesthesia using a numerical evaluation scale.
Considering the state of consciousness after general anesthesia, the interview is conducted the day after surgery.
Key secondary outcomes
Hoarseness after anesthesia
Sore throat after anesthesia
These two points are also evaluated on the numerical evaluation scale in the same way as the feeling of thirst.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After tracheal intubation management under general anesthesia, the lips and nostrils are sealed with a medical film. Sealing begins immediately after intubation and the film is removed prior to awakening of anesthesia.
Interventions/Control_2
After tracheal intubation management under general anesthesia, apply a medical film only around the lips, but do not cover the lips themselves. Coverage begins immediately after intubation and the film is removed prior to awakening of 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients who perform general anesthesia management
1. 20 years old and over
2. Japanese, men and women
3. Patients with ASA PS 1-2
4. Patients who have consented to participate in the study
5. Cases in which the symptoms can be heard from the patient the day after surgery
Cases that meet all of the above five points are targeted.
Key exclusion criteria
1. Under 20 years old
2. Patients with ASA-PS 3 or higher
3. Emergency surgery cases
4. Prone position case
Cases that meet any of the conditions are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | AZUSA |
| Middle name | |
| Last name | INADA |
Organization
Chiba Emergency Medical Center
Division name
Anesthesia
Zip code
261-0012
Address
3-32-1 Isobe Mihama-ku, Chiba city, Chiba, Japan
TEL
047-279-2211
tasuica@gmail.com
Public contact
Name of contact person
| 1st name | AZUSA |
| Middle name | |
| Last name | INADA |
Organization
Chiba Emergency Medical Center
Division name
Anesthesia
Zip code
261-0012
Address
3-32-1 Isobe Mihama-ku, Chiba city, Chiba, Japan
TEL
047-279-2211
Homepage URL
tasuica@gmail.com
Sponsor or person
Institute
Chiba Emergency Medical Center
Institute
Department
Personal name
Funding Source
Organization
Chiba Emergency Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Emergency Medical Center
Address
3-32-1 Isobe Mihama-ku, Chiba city, Chiba, Japan
Tel
047-279-2211
tasuica@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
千葉県救急医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 05 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054492
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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