Tokyo, Jan. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060265) titled 'Elucidation of Changes in Plasma Concentration and Protein Binding Ratio of Propofol during Co-administration with Remimazolam' on Jan. 6.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - general anesthesia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to elucidate whether co-administration of remimazolam during propofol-induced general anesthesia affects the plasma concentration and protein binding of propofol, and to determine the extent of these changes.
Basic objectives2 - Pharmacokinetics
Intervention:
Interventions/Control_1 - Co-administration of remimazola
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients undergoing elective non-cardiac surgery under general anesthesia
Key exclusion criteria - Patients with an allergy to propofol
Patients with an allergy to remimazolam
Patients who are on regular or as-needed benzodiazepine therapy
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 07 Day
Anticipated trial start date - 2028 Year 04 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068011
Disclaimer: Curated by HT Syndication.
