Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062363) titled 'A study investigating how blood pressure and heart rate change when starting general anesthesia with different medications (propofol or remimazolam)' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Osaka Dental University

Condition: Condition - Young and healthy adult patients aged 18 to 39 years with an ASA physical status of 1 or 2 undergoing oral and maxillofacial surgery. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Propofol is currently the most widely used general anesthetic and is a highly useful agent; however, it has certain limitations, including the risk of allergic reactions in patients with soybean or egg allergies and the occurrence of injection pain. Furthermore, propofol is characterized by a relatively strong cardiovascular suppressive effect. On the other hand, although basic research has reported that the effects of remimazolam, a novel general anesthetic for induction and maintenance, on hemodynamics are milder than those of propofol, there have been no clinical reports comparing the two when used in combination with opioids in actual clinical practice. Clarifying the effects of remimazolam on hemodynamics in a clinical setting through this study is expected to expand the options available for total intravenous anesthesia. Basic objectives2 - Pharmacodynamics

Intervention: Interventions/Control_1 - After obtaining control values (pre-anesthesia values), remifentanil is administered at 0.3 ug/kg/min for 1 minute. Propofol is administered via TCI at 5 ug/ml (maintained at 3 times the effect-site concentration for loss of consciousness). Following loss of consciousness, rocuronium (0.6 mg/kg) is administered, and endotracheal intubation is performed at least 5 minutes after administration when the train-of-four (TOF) count reaches 0. Interventions/Control_2 - After obtaining control values (pre-anesthesia values), remifentanil is administered at 0.3 ug/kg/min for 1 minute. Propofol is administered via TCI at 4 ug/ml (maintained at 3 times the effect-site concentration for loss of consciousness). Following loss of consciousness, rocuronium (0.6 mg/kg) is administered, and endotracheal intubation is performed at least 5 minutes after administration when the train-of-four (TOF) count reaches 0.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Age: Healthy adults aged 18 to 39 years (ASA-PS physical status 1 or 2) Patient Background: Patients scheduled to undergo oral and maxillofacial surgery under general anesthesia Consent: Patients who have provided written informed consent after receiving a sufficient explanation regarding participation in this study Key exclusion criteria - 1.Individuals objectively judged to lack the capacity to give informed consent 2.Patients with cardiovascular diseases (including hypertension) 3.Pregnant women 4.Patients with an ASA physical status (ASA-PS) of 3 or higher 5.Patients with a Body Mass Index (BMI) of 30 kg/m2 or higher 6.Patients with a history of soybean or egg allergy 7.Patients who cannot or do not provide consent Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 07 Month 01 Day Date of IRB - 2025 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 12 Month 18 Day Last follow-up date - 2026 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071373

Disclaimer: Curated by HT Syndication.