UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041438
Receipt number R000047197
Scientific Title Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam
Date of disclosure of the study information 2020/08/17
Last modified on 2024/02/29 15:31:09

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Basic information

Public title

Elucidation of pharmacokinetics at the end of remimazolam administratoin

Acronym

Elucidation of pharmacokinetics at the end of remimazolam administratoin

Scientific Title

Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam

Scientific Title:Acronym

Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam

Region

Japan


Condition

Condition

General anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the pharmacokinetics of remimazolam at the end of continuous administration

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood remimazolam concentration

Key secondary outcomes

Remimazolam metabolite levels in blood, remimazolam and metabolite levels in urine


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

General anesthesia with continuous administration of remimazolam

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Age at the time of obtaining consent is 20 years or older
2. Gender: Any
3. Patients scheduled for spinal surgery who are scheduled for general anesthesia with remimazolam
4. Patients who are scheduled to be hospitalized from at least one day before surgery to the day after the surgery
5. Patients entering the intensive care unit after scheduled surgery
6. ASA-PS (American Society of Anesthesiologist-Physical Status): 1-3 patients
7. Those who obtained consent for this research by signing the consent form

Key exclusion criteria

1. Patients with severe respiratory, circulatory, central nervous system, digestive system, liver, kidney, hematopoietic functions, etc.
2. Emergency surgery
3. Patients scheduled to undergo surgery other than spine at the same time
4. Patients with a history of hypersensitivity to benzodiazepines or flumazenil
5. Patients with a history of hypersensitivity to remifentanil, fentanyl, rocuronium, sugammadex or other components of the drug required to maintain general anesthesia.
6. Patients with acute angle-closure glaucoma
7. Patients with myasthenia gravis
8. Shock patients, coma patients, acute alcoholics with suppressed vital signs
9. Patients who are prone to respiratory depression such as coma due to head injury or brain tumor
10. Patients with a history of seizures
11. Patients with bronchial asthma
12. Patients with organic abnormalities in the brain
13. Patients who used benzodiazepines within 1 week before surgery
14. Patients with a history of severe allergies
15. Patients who have a history of drug dependence or alcohol dependence
16. Pregnant patient
17. Lactating patients
18. Patients who are judged to have a lack of consent due to dementia and other factors
19. Patients who are judged to be excluded by other investigators/partners

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name SUZUKI

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

4313192

Address

1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN

TEL

053-435-2111

Email

suzukiy@hama-med.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name SUZUKI

Organization

Hamamatsu University School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

4313192

Address

1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN

TEL

053-435-2111

Homepage URL


Email

suzukiy@hama-med.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Intensive Care Medicine, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

Ethics Committee of Hamamatsu University School of Medicine

Address

1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN

Tel

053-435-2680

Email

rinri@hama-med.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



Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 17 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

2020 Year 08 Month 04 Day

Date of IRB

2020 Year 08 Month 04 Day

Anticipated trial start date

2020 Year 08 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

2020 Year 08 Month 17 Day

Last modified on

2024 Year 02 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047197


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name