UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056057 |
|---|---|
| Receipt number | R000064059 |
| Scientific Title | Dosage of Pethidine Hydrochloride during Bronchoscopy and Associated Factors |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/06 10:25:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Dosage of Pethidine Hydrochloride during Bronchoscopy and Associated Factors
Acronym
Dosage of Pethidine Hydrochloride during Bronchoscopy and Associated Factors
Scientific Title
Dosage of Pethidine Hydrochloride during Bronchoscopy and Associated Factors
Scientific Title:Acronym
Dosage of Pethidine Hydrochloride during Bronchoscopy and Associated Factors
Region
| Japan |
Condition
Condition
Respiratory diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated factors that affect the pethidine dosage during bronchoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pethidine dosage during bronchoscopy.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Between January 2023 and December 2023, 205 patients underwent bronchoscopy using pethidine hydrochloride in the respiratory medicine department of our hospital were included in the study.
Key exclusion criteria
One case was excluded due to missing data in the nursing records.
Target sample size
204
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
respiratory24@outlook.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
Homepage URL
respiratory24@outlook.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
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
Matsuyama Red Cross Hospital
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
Tel
0899241111
respiratory24@outlook.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 | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.matsuyama.jrc.or.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.matsuyama.jrc.or.jp/
Number of participants that the trial has enrolled
205
Results
Multiple regression analysis showed that the dose of pethidine hydrochloride was significantly associated with examination time, but no association was observed with comorbidities or procedure.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age group was 74.0 years, 116 were male, weighed 56.0 kg, 35 were current smokers, and 26 were taking a beta-blocker concomitantly. The examination time for bronchoscopy was 30.0 minutes. The dosages were 48.0 mg of 8% lidocaine, 26.3 mg of pethidine hydrochloride, 200.0 mg of 1% lidocaine, and 2.0 mg of midazolam. Pethidine hydrochloride was added in 61.8% of cases, both immediately after the start of bronchoscopy and over time.
Participant flow
none
Adverse events
There was no hypotension during the examination, bradycardia was mild in all three cases, and naloxone was not used during the examination.
Outcome measures
Pethidine hydrochloride dosage
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study included 205 cases in which bronchoscopy was performed using pethidine hydrochloride in the respiratory medicine department of our hospital between January 2023 and December 2023. Using medical records and nursing records, a retrospective analysis was performed using data on patient background, bronchoscopy technique, and progress.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064059
