UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057496 |
|---|---|
| Receipt number | R000065696 |
| Scientific Title | Role of Nebulized dexmedetomidine in Reducing Patient Cough and Discomfort in Flexible Bronchoscopy: a randomized double-blind study |
| Date of disclosure of the study information | 2025/10/02 |
| Last modified on | 2025/04/03 03:36:53 |
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Basic information
Public title
Role of Nebulized dexmedetomidine in Reducing Patient Cough and Discomfort in Flexible Bronchoscopy: a randomized double-blind study
Acronym
Role of Nebulized dexmedetomidine in Reducing Patient Cough and Discomfort in Flexible Bronchoscopy: a randomized double-blind study
Scientific Title
Role of Nebulized dexmedetomidine in Reducing Patient Cough and Discomfort in Flexible Bronchoscopy: a randomized double-blind study
Scientific Title:Acronym
Role of Nebulized dexmedetomidine in Reducing Patient Cough and Discomfort in Flexible Bronchoscopy: a randomized double-blind study
Region
| Africa |
Condition
Condition
prospective double-blinded randomized control trial
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the Patient discomfort to bronchoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Patient discomfort to bronchoscopy
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
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients belonging to Group C (control group) received total volume of 10ml contain 4 ml of 4% lidocaine (160 mg of lidocaine)+ normal saline
Interventions/Control_2
Patients belonging to Group E (expermental group) received total volume of 10ml contain 4 ml of 4% lidocaine (160 mg of lidocaine)+ dexmedetomidine
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA class I, II or III undergoing diagnostic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology were permitted
Key exclusion criteria
, we will not include patients requiring cryobiopsy or endobronchial ultrasound because these procedures are performed under deep sedation including fiberoptic intubation in our institution
Patients on opioid therapy, central nervous system depressants, or with hepatic or renal disease, pregnancy or lactation, psychiatric disorder, and/or bleeding disorder are not included. We also excluded patients established respiratory depression; sleep apnea, a history of hypersensitivity to one of the drugs and/or not willing to participate in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | noha |
| Middle name | |
| Last name | afify |
Organization
faculty of medicine- menoufia university
Division name
department of anesthesia
Zip code
32511
Address
25- yassen abdel ghaffar - shebin elkom
TEL
01069113014
nohaafify2014@gmail.com
Public contact
Name of contact person
| 1st name | noha |
| Middle name | |
| Last name | afify |
Organization
faculty of medicine menoufia university
Division name
department of anesthesia
Zip code
32511
Address
25- yassen abdel ghaffar - shebin elkom
TEL
01069113014
Homepage URL
nohaafify2014@gmail.com
Sponsor or person
Institute
faculty of medicine - menoufia university
Institute
Department
Personal name
noha afify
Funding Source
Organization
faculty of medicine menoufia university
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
faculty of medicine menoufia university
Address
Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St
Tel
0482330325
medcine@menofia.edu.eg
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
| 2025 | Year | 10 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065696
