Tokyo, Jan. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060266) titled 'Changes in blood concentration and protein binding of the benzodiazepine sedative remimazolam during co-administration with the general anesthetic propofol' 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 - The aim of this study is to elucidate the actual changes in plasma concentration and protein binding of remimazolam during concomitant administration with propofol.
Basic objectives2 - Pharmacokinetics
Intervention:
Interventions/Control_1 - After the induction of general anesthesia with remimazolam is completed, continuous infusion of propofol is initiated.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients undergoing elective surgery under general anesthesia
ASA classification 1 to 3
No allergy to remimazolam or propofol
Obtain written consent from the person or legally acceptable person
Key exclusion criteria - ASA classification 4 or higher
Allergic to remimazolam and propofol
Written consent cannot be obtained from the person himself/herself or a legal representative
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2023 Year 10 Month 01 Day
Anticipated trial start date - 2027 Year 04 Month 01 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=R000058881
Disclaimer: Curated by HT Syndication.
