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

Not Applicable

• Conditions: on-emergency patients undergoing surgery under general anesthesia

• Registration Number: JPRN-jRCTs041210009
• Lead Sponsor: akajima Yoshiki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive effect site concentration of remimazolam (EC50) for successful i-gel insertion in 50% of patients

Secondary Outcome Measures

Name	Time	Method
Predictive effect site concentration of remi-mazolam (EC95) for successful i-gel insertion in 95% of patients<br>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)