Pharmacodynamic interaction between remimazolam and remifentanil during anesthesia induction - randomized trial -

JRCT ID: jRCTs031230301

Registered date:21/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not limited
• Date of first enrollment: 17/06/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Remifentanil concentration is kept constant and remimazolam concentration is gradually increased, or remimazolam concentration is kept constant and remifentanil concentration is gradually increased

Outcome(s)

• Primary Outcome: Remimazolam and remifentanil effect-site concentrations at loss of consicousness, and to suppress the sympathetic response to laryngoscopy and tracheal intubation
• Secondary Outcome: Electroencephalogram monitoring, invasive arterial blood pressure , heart rate, and effect-site concentrations fof remimazolam and remifentanil

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(1) Patients aged between 18 and 89 years undergoing general anesthesia for elective surgery at Yokohama City University Hospital
(2) Patients who have an arterial catheter inserted into the radial artery for intraoperative and postoperative blood pressure measurements or blood sampling
(3) Patients who have given written consent to participate in this study

• Exclude criteria: Patients for whom remimazolam, remifentanil, and rocuronium are contraindicated in the Japanese package inserts; patients receiving benzodiazepines for >=1 week within 3 months; patients with a history of drug dependence; organic brain disease; pregnant and lactating women; American Society of Anesthesiologists physical status is >=3; body mass index >=30 kg/m2; Glasgow coma scale <15; or patients deemed ineligible by the study physician

Related Information

• Primary Sponsor: Masui Kenichi