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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041210009
Enrollment
35
Registered
2021-04-19
Start date
2021-05-31
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

Non-emergency patients undergoing surgery under general anesthesia

Interventions

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. A

Sponsors

Nakajima Yoshiki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Predictive effect site concentration of remimazolam (EC50) for successful i-gel insertion in 50% of patients

Secondary

MeasureTime frame
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)

Contacts

Public ContactHisako Nishimoto

Hamamatsu University Hospital

41237099@hama-med.ac.jp+81-53-435-2286

Outcome results

None listed

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