Predictive effect of remi-mazolam when supraglottic device (i-gel) is inserted.

JRCT ID: jRCTs041210009

Registered date:19/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-emergency patients undergoing surgery under general anesthesia
• Date of first enrollment: 31/05/2021
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Remimazolam is administered at the assigned rapid intravenous dose, and at the same time, the continuous administration rate is started and the continuous administration is continued for 10 minutes. Administer fentanyl 4 minutes before i-gel insertion and attempt i-gel insertion.

Outcome(s)

• Primary Outcome: Predictive effect site concentration of remimazolam (EC50) for successful i-gel insertion in 50% of patients

Secondary Outcome

Predictive effect site concentration of remi-mazolam (EC95) for successful i-gel insertion in 95% of patients
Changes in blood pressure / heart rate and changes in EEG monitor at each point (before the start of general anesthesia, before and after i-gel insertion)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

1. Patients aged between 20 and 45 at the time of consent
2. Gender: No matter
3.Patients planning to insert i-gel in non-emergency (scheduled / temporary) surgery
4. ASA (American Society of Anesthesiologists) Grade I or II patients
5. Persons who have obtained consent for this research by signing the consent form

Exclude criteria

1. Those who are expected to have difficulty intubation (trismus, Malampati Grade III IV, etc.)
2. Patients undergoing surgery requiring tracheal intubation
3. Those with symptoms of respiratory tract infection
4. Patients with a history of hypersensitivity to benzodiazepines or flumazenil
5. Severe obesity (BMI 35 and above)
6. Pregnant patients
7. Lactating women and puerperal women
8. Those who may be aspirated
9. Persons with a history of hypersensitivity to Remimazolam
10. Patients who are excluded from other investigators / shared doctors

Related Information

• Primary Sponsor: Nakajima Yoshiki