Comparison of effects of remimazolam and propofol on mask ventilation during general anesthesia induction: a randomized controlled trial

UMIN ID: UMIN000053553

Registered date:07/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Mask ventilation during general anesthesia induction
• Date of first enrollment: 2024/02/25
• Target sample size: 76
• Countries of recruitment: Asia(except Japan)
• Study type: Interventional

Intervention(s)

In the randomization unit 1, loss of consciousness during general anesthesia is performed using intravenous remimazolam.
In the randomization unit 2, loss of consciousness during general anesthesia is performed using intravenous propofol.

Outcome(s)

• Primary Outcome: Warters grading scale
• Secondary Outcome: Han's grading scale Vital signs during general anesthesia - heart rate - blood pressure - pulse oximeter Mallanpati score Thyromental distance Cormack-Lehane grade

Key inclusion & exclusion criteria

• Age minimum: 19years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: - Current C-spine diseases or history of c-spine surgery - Edentulous - Mechanical airway obstruction such as pharyngeal neoplasm or abscess - Morbid obese - Risk of regurgitation and pulmonary aspiration - Sleep apnea - Craniofacial anomaly - History of allergic reaction to benzodiazepine or propofol - Chronic use of opioids, benzodiazepine, or antipsychotic medications - Pregnancy - Acute narrow angle glaucoma - Myasthenia gravis - Cerebral infarction

Related Information

• Primary Sponsor: Seoul National University Bundang Hospital
• Source(s) of Monetary Support: HANA PHARM CO., LTD.