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A study on the efficacy of the loss of response to jaw thrust as a clinical test to assess adequate depth of anesthesia using remimazolam besylate and the dose required for the loss of response.

A study on the efficacy of the loss of response to jaw thrust as a clinical test to assess adequate depth of anesthesia using remimazolam besylate and the dose required for the loss of response.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031210554
Enrollment
70
Registered
2022-01-17
Start date
2022-02-08
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

Subjects are given 100% oxygen at 6 L / min through a face mask for at least 3 minutes, and then sedation is started. In the Remimazolam group (group R), Remimazolam is stated at 12 mg/kg/hr. In the p

Sponsors

Okuda Yasuhisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with written consent to participate in this study. 2) Patients aged between 20 and 65 at the time of consent. 3) American Society of Anesthesiologists (ASA) Grade I or II patients. 4) Patients whose surgical purpose is other than heart surgery.

Exclusion criteria

Exclusion criteria: 1) Patients undergoing emergency surgery. 2) Patients who may be pregnant. 3) Patients who are expected to have difficulty airway management or intubation. 4) BMI 28 and above. 5) Patients who have high risk of aspiration. 6) Patients with liver dysfunction: Child-pugh classification B or higher. 7) Patients with contraindications to propofol or remimazolam. 8) Patients with a history of alcoholism or drug abuse. 9) Patients who regularly use sedatives. 10) Patients with a history of cervical spine / cervical cord disease. 11) Patients with no eyelashes. 12) Patients with a history of cranial nerve system disease.

Design outcomes

Primary

MeasureTime frame
The proportion of subjects with the loss of jaw thrust reflex.

Secondary

MeasureTime frame
The dose of Remimazolam required for the loss of jaw thrust reflex. The dose of Remimazolam required for the loss of eyelash reflex. Bispectral Index (BIS) value at the time of the loss of jaw thrust reflex.

Contacts

Public ContactHayato Arime

Dokkyo Medical University Saitama Medical Center

h-arime@dokkyomed.ac.jp+81-489654948

Outcome results

None listed

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