Investigation of factors affecting the in vivo degradation of the intravenous anesthetic remimazolam.

UMIN ID: UMIN000054590

Registered date:10/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Dental and Oral Surgical Diseases
• Date of first enrollment: 2024/06/10
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Remimazolam blood concentration at various time points after completion of remimazolam administration
• Secondary Outcome: - Patient information: age, weight, height, BMI, gender, medical history, medications, and laboratory test results - Surgical information: operation details, operation time, anesthesia time - Time from the end of remimazolam administration to extubation (awake time) - Blood concentration of CNS7054 at each time point after completion of remimazolam administration - Pharmacokinetic parameters such as AUC (area under the blood concentration-time curve) of remimazolam and CNS7054 - BIS values at the end of remimazolam and at the time of extubation or flumazenil administration - Remimazolam total dose, average rate of administration - Remifentanil total dose, mean rate of administration - BIS values before anesthetic administration, during loss of consciousness, and during maintenance of anesthesia - Time from remimazolam administration to loss of consciousness - Number of bolus doses of remimazolam

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude criteria: 1. Patients with contraindications to remimazolam, remifentanil, or rocuronium 2. Patients requiring preanesthetic medication 3. Other patients deemed inappropriate for participation in the study by the principal investigator and research coordinators.

Related Information

• Primary Sponsor: Okayama University
• Source(s) of Monetary Support: Okayama University