Study on the interaction between remimazolam and inhaled anesthetics (sevoflurane)

JRCT ID: jRCT1041230104

Registered date:10/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patient undergoing general anesthesia and i-gel insertion
• Date of first enrollment: 10/11/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Remimazolam and sevoflurane are administered at assigned doses during general anesthesia.

Outcome(s)

• Primary Outcome: Bispectral index (with a cutoff value of 60)
• Secondary Outcome: Bispectral index (50 and 70 as cutoff values, respectively)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 60age old

Include criteria

1. patients who are between 40 and 60 years of age at the time of consent
2. patients scheduled for i-gel insertion for non-emergency (scheduled or temporary) surgery
3. patients with ASA (American Society of Anesthesiologists) Class I or II status
4. patients who have given their consent to this study by signing the consent form

Exclude criteria

1. those who are expected to have difficulty in intubation (e.g., with impaired opening, Mallampati Grade III or IV, etc.) 2.
2. patients undergoing surgery requiring intubation
3. patients with symptoms of airway infection 4. benzodiazepines or benzodiazepines
4. patients with a history of hypersensitivity to benzodiazepines or flumazenil
5. patients who should avoid sevoflurane (e.g., history of malignant hyperthermia or family history of malignant hyperthermia)
6. patients with a history of hypersensitivity to rocuronium
7. severely obese (BMI > 35)
Pregnant patients
9. nursing mothers and postpartum mothers
10. patients with the possibility of aspiration
11.Patients with a history of hypersensitivity to remimazolam
12.Patients with a history of glaucoma
13.Patients who regularly use benzodiazepines
14.Persons with psychiatric disorders
15. other patients who are judged to be exempted by the principal investigator/associate investigator

Related Information

• Primary Sponsor: Kobayashi Kensuke