Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061870) titled 'Correlation between the predicted effect-site concentration and cerebrospinal fluid concentration of remimazolam' on June 12.
Study Type:
Observational
Primary Sponsor:
Institute - Niigata University
Condition:
Condition - Patients aged 18 years or older with ASA physical status 1-3 who are undergoing spinal surgery requiring a dural incision
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 18
years-old
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070420
Disclaimer: Curated by HT Syndication.
