Effect of flumazenil administration on nausea and vomiting after oral surgery

UMIN ID: UMIN000055097

Registered date:01/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: jaw deformity
• Date of first enrollment: 2024/08/01
• Target sample size: 76
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Flumazenil group will receive 0.2mg(2mL) of flumazenil after remimazolam anesthesia.
Flumazenil non-treatment group will receive 2mL of saline after remimazolam anesthesia.

Outcome(s)

• Primary Outcome: Incidence of PONV (early period: within 2 hours after the end of anesthesia, late period: 2 - 24 hours after the end of anesthesia)
• Secondary Outcome: Patient background (age, sex, height, weight, smoking history, and presence or absence of motion sickness/ PONV) surgical and anesthetic factors (operation name, operation time, anesthesia time, total infusion volume, blood loss, intraoperative opioid use, and postoperative opioid use) speed of awakening (time from study drug administration to extubation and MOAA/S score to 5) degree of PONV (maximum Numerical Rating Scale (NRS) value), presence or absence of vomiting up to 24 hours after the end of anesthesia, number of ondansetron and metoclopramide doses administered Quality of postoperative recovery (QoR-40)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude criteria: <20 or >50 years of age, ASA-PS 3 or higher, patient who did not give consent for this study,use of antiemetics or benzodiazepines within 24 h before surgery, contraindicated for administration of medications used in this study, emergency surgery

Related Information

• Primary Sponsor: Tokyo Dental College
• Source(s) of Monetary Support: Self funding