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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032230
Receipt No. R000036694
Scientific Title Randomized single-blind comparative study of midazolam alone administration and midazolam/pethidine combination administration against pain level during respiratory endoscopy (KURM005study)
Date of disclosure of the study information 2018/08/15
Last modified on 2021/06/09

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Basic information
Public title Randomized single-blind comparative study of midazolam alone administration and midazolam/pethidine combination administration against pain level during respiratory endoscopy (KURM005study)
Acronym Comparative study of analgesic/sedating midazolam alone and midazolam/pethidine combination at the time of respiratory endoscopy
Scientific Title Randomized single-blind comparative study of midazolam alone administration and midazolam/pethidine combination administration against pain level during respiratory endoscopy (KURM005study)
Scientific Title:Acronym Comparative study of analgesic/sedating midazolam alone and midazolam/pethidine combination at the time of respiratory endoscopy
Region
Japan

Condition
Condition Lung tumor and mediastinal tumor
Classification by specialty
Pneumology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluated the effectiveness in this study by hoping that the pain will soften than midazolam alone administration by concomitant administration of midazolam/pethidine. At the same time, we evaluate safety. If this test improves the suffering of the patients during the respiratory endoscopy, psychological refusal to the regeneration respiratory bronchoscopy will be reduced and more appropriate lung cancer treatment will be expected to be performed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The visual analogue scale (VAS) of the questionnaire "You may reexecute respiratory endoscopy".
Key secondary outcomes Percentage of patients who responded that they may reexecute respiratory endoscopy of subjects
VAS value of degree of suffering and cough during examination by the subject.
Dosage of xylocaine and midazolam (mg).
The VAS of the cough degree of the examinee.
Effectiveness and safety. (modified observer's assessment of alertness/sedation scale (moaa/s)under examination, tissue collection rate, diagnostic rate, examination time, SpO2, blood pressure, history of use of Flumazenil, adverse events, VAS in a questionnaire.)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 At the start of respiratory endoscopy, administration of 5 mL of physiological saline (placebo) and 2 mL of midazolam (1mg/mL).
Midazolam (1 mg / mL) is additionally administered 1 mL at a time depending on the patient's pain under examination.
Interventions/Control_2 At the start of bronchoscopy, 5 mL of pethidine hydrochloride (3.5 mg/mL) and 2 mL of midazolam (1 mg/mL).
Midazolam (1mg/mL) is additionally administered 1 mL at a time depending on the patient's pain under examination
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients whose age is between 20 and 80 years old when obtaining consent.
(2) Patients scheduled to undergo respiratory endoscopy for biopsy of lung tumor or mediastinal tumor.
(3) Patietns who obtained document consent by their own voluntary intention concerning participation in this exam.
Key exclusion criteria (1) Patients who are allergic to the drugs used in this study and have drug hypersensitivity
(2) Patients with acute narrow angle glaucoma
(3) Patients with myasthenia gravis
(4) Uncontrollable bronchial asthma patients
(5) Patients whose severe respiratory depression is confirmed before the examination
(6) Patients having heart failure secondary to chronic lung disease
(7) Patients in convulsive state
(8) Patients whose severe liver failure has been confirmed
(9) Pregnant women and patients who may be pregnant or breast-feeding patients
(10) Patients taking HIV protease inhibitors or monoamine inhibitors
(11) Patients taking orally administered opioids
(12) Other patients judged inappropriate by the person in charge of this examination
Target sample size 100

Research contact person
Name of lead principal investigator
1st name MOTOKO
Middle name
Last name TACHIHARA
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code 6500017
Address 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan
TEL 078-382-5660
Email mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name MOTOKO
Middle name
Last name TACHIHARA
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code 6500017
Address 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan
TEL 078-382-5660
Homepage URL
Email mt0318@med.kobe-u.ac.jp

Sponsor
Institute Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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 KOBE Univ. Hosp. CTRC
Address 7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan
Tel 078-382-6669
Email kainyu@med.kobe-u.ac.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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 15 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 100
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 Completed
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 07 Month 24 Day
Anticipated trial start date
2018 Year 08 Month 15 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
2021 Year 07 Month 31 Day
Date trial data considered complete
2021 Year 07 Month 31 Day
Date analysis concluded
2022 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 13 Day
Last modified on
2021 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036694

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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