UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056390 |
|---|---|
| Receipt number | R000064429 |
| Scientific Title | Distress during Bronchoscopy in Patients with Throat Anesthesia using Lidocaine gargle: A Prospective Study |
| Date of disclosure of the study information | 2024/12/08 |
| Last modified on | 2024/12/08 12:18:42 |
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Basic information
Public title
Distress during Bronchoscopy in Patients with Throat Anesthesia using Lidocaine gargle: A Prospective Study
Acronym
Distress during Bronchoscopy in Patients with Throat Anesthesia using Lidocaine gargle: A Prospective Study
Scientific Title
Distress during Bronchoscopy in Patients with Throat Anesthesia using Lidocaine gargle: A Prospective Study
Scientific Title:Acronym
Distress during Bronchoscopy in Patients with Throat Anesthesia using Lidocaine gargle: A Prospective Study
Region
| Japan |
Condition
Condition
Respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the pain level during bronchoscopy using pharyngeal anesthesia with lidocaine gargle and examine its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of people who scored 2 or less on a 5-point scale using a visual analog scale (VAS) for the questionnaire item (a. Was the anesthesia for your throat administered before the examination painful?)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Patients suitable for bronchoscopy
(b) Patients undergoing elective bronchoscopy
(c) Patients who have not previously undergone bronchoscopy
(d) Patients with a performance status of 2 or less
(e) Patients with a mental condition that allows for a questionnaire survey
(f) Patients who have given written informed consent
(g) Patients not using opioids
(h) Patients aged 20 years or older (regardless of gender)
Key exclusion criteria
(a) Patients with contraindications for bronchoscopy
(b) Patients with a history of drug allergies
(c) Patients with mental conditions that make it difficult to participate in clinical trials
(d) Patients who are otherwise deemed by a physician to be inappropriate for enrollment in this study
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Minami |
Organization
Hosoya hospital
Division name
Department of Respiratory medicine
Zip code
715-0014
Address
102 Nanokaichicho Ibara city
TEL
09064054337
d-minami@bj8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Minami |
Organization
Hosoya hospital
Division name
Department of Respiratory medicine
Zip code
715-0014
Address
102 Nanokaichicho Ibara city
TEL
09064054337
Homepage URL
d-minami@bj8.so-net.ne.jp
Sponsor or person
Institute
Hosoya hospital
Institute
Department
Personal name
Funding Source
Organization
Hosoya hospital
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
Himeji Saint Mary's Hospital
Address
650 Nibuno, Himeji city, hyogo
Tel
09064054337
d-minami@bj8.so-net.ne.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
| 2024 | Year | 12 | Month | 08 | 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
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064429
