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.

JRCT ID: jRCT1031210554

Registered date:17/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-emergency patients undergoing surgery under general anesthesia
• Date of first enrollment: 08/02/2022
• Target sample size: 70
• Study type: Interventional
• Intervention(s): 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 propofol group (group P), Propofol is started at 120 mg/kg/hr after infusion of 20mg Lidocaine hydrochloride as prevention of angialgia. Subjects are asked to count up from the start of sedation. When the counting stops, subjects are checked for eyelash reflex every 5 seconds. Once the eyelash reflex disappears, the jaw is thrust gently every 5 seconds. Giving the sedatives is discontinued when there is no longer any motor response (coughing, gagging, body movement, etc.) to jaw thrust. At this point, it was determined that the jaw thrust reflex had disappeared.

Outcome(s)

• Primary Outcome: The proportion of subjects with the loss of jaw thrust reflex.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Okuda Yasuhisa