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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047798
Receipt No. 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

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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
Email 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
Email tasuica@gmail.com

Sponsor
Institute Chiba Emergency Medical Center
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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