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

Exploration of Factors Influencing the Pharmacokinetics of Remimazolam - A Cofort Study in Dental and Oral Surgery Patients. - Exploring Factors Affecting Remimazolam Pharmacokinetics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054590
Enrollment
40
Registered
2024-06-10
Start date
2024-06-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental and Oral Surgical Diseases

Interventions

None listed

Sponsors

Okayama University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing general anesthesia at the Department of Dental Anesthesiology, Okayama University Hospital between the date of approval by the director of the research institution and December 31, 2026. 2. Patients who are able to obtain free and voluntary written consent for participation in the study 3. Patients scheduled for total intravenous anesthesia with remimazolam and remifentanil 4. Patients who are at least 18 years old and less than 50 years old at the time of obtaining consent 5. Patients whose Body Mass Index (BMI) is less than 30 6. Patients whose general condition is PS-1 or PS-2 on the American Society of Anesthesiologists Preoperative Status Classification (ASA-PS). 7. Patients whose scheduled anesthesia time is less than 4 hours. 8. Patients scheduled for dental procedures or minimally invasive oral surgery such as tooth extraction. 9. Patients who are not considered to require narcotic analgesics for postoperative analgesia.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Remimazolam blood concentration at various time points after completion of remimazolam administration

Secondary

MeasureTime frame
- 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

Countries

Japan

Contacts

Public ContactHitoshi Higuchi

Okayama University Hospital Department of Dental Anesthesiology

higuti@md.okayama-u.ac.jp086-235-6721

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026