UMIN-ICDS Clinical Trial

Public title

Correlation between the predicted effect-site concentration and cerebrospinal fluid concentration of remimazolam

Acronym

Correlation between the predicted effect-site concentration and cerebrospinal fluid concentration of remimazolam

Scientific Title

Correlation between the predicted effect-site concentration and cerebrospinal fluid concentration of remimazolam

Scientific Title:Acronym

Correlation between the predicted effect-site concentration and cerebrospinal fluid concentration of remimazolam

Region

Japan

Condition

Patients aged 18 years or older with ASA physical status 1-3 who are undergoing spinal surgery requiring a dural incision

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the correlation between the predicted effect-site concentration calculated using an existing pharmacokinetic model and the actual cerebrospinal fluid concentration of remimazolam.

Basic objectives2

PK,PD

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cerebrospinal fluid concentration of remimazolam at the time of dural incision.

Key secondary outcomes

Predicted effect-site concentration of remimazolam at the time of dural incision.
Blood concentration of remimazolam at the time of dural incision.
Blood and cerebrospinal fluid concentrations of CNS7054 at the time of dural incision.
Bispectral Index (BIS) value.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients aged 18 years or older with ASA physical status 1-3 who are scheduled to undergo spinal surgery requiring a dural incision.
2) Patients who have provided written informed consent to participate in this study.

Key exclusion criteria

1)Patients with a history of hypersensitivity to any component of the administered drugs
2)Patients with acute angle-closure glaucoma
3)Patients with a history of neuromuscular disorders, including myasthenia gravis
4)Patients in shock
5)Patients with impaired consciousness
6)Patients with a history of drug dependence
7)Patients with hepatic impairment
8)Patients with a body mass index (BMI) > 35 kg/m2 or < 14 kg/m2
9)Patients under 18 years of age
10)Pregnant women
11)Patients with an ASA physical status of 4 or higher
12)Patients with cognitive impairment
13)Patients deemed ineligible by the investigator

Target sample size

40

Name of lead principal investigator

1st name	Kenta
Middle name
Last name	Furutani

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Anesthesiology

Zip code

951-8520

Address

1-754 Asahi-machi-dori, Chuo Ward, Niigata City, Niigata Prefecture

TEL

025-227-2328

Email

masui@med.niigata-u.ac.jp

Name of contact person

1st name	Yoshihiro
Middle name
Last name	Naito

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Anesthesiology

Zip code

951-8520

Address

1-754 Asahi-machi-dori, Chuo Ward, Niigata City, Niigata Prefecture

TEL

025-227-2328

Homepage URL

Email

m10068yn@jichi.ac.jp

Institute

Niigata University

Institute

Department

Personal name

Kenta Furutani

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Niigata University Graduate School of Medical and Dental Sciences

Address

1-754 Asahi-machi-dori, Chuo Ward, Niigata City, Niigata Prefecture

Tel

025-227-2328

Email

masui@med.niigata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学医歯学総合病院

Date of disclosure of the study information

2026

Year

06

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

04

Month

15

Day

Date of IRB

2026

Year

04

Month

15

Day

Anticipated trial start date

2026

Year

06

Month

12

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is an observational study of patients undergoing spinal surgery requiring a dural incision under general anesthesia.
Cerebrospinal fluid and arterial blood samples will be collected at the time of dural incision to measure the concentrations of remimazolam and its metabolite (CNS7054).
Furthermore, this study will evaluate the relationship between the predicted effect-site concentration calculated from an existing pharmacokinetic model and each measured drug concentration.

Registered date

2026

Year

06

Month

11

Day

Last modified on

2026

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070420