Comparison of the preventive effect of ondansetron and dexamethasone on nausea and vomiting after orthognathic surgery between remimazolam and propofol anesthesia.

UMIN ID: UMIN000051512

Registered date:03/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing orthognathic surgery
• Date of first enrollment: 2023/07/04
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the propofol group, anesthesia is induced with continuous infusion of propofol at a rate of 4.0 mcg/ml (target effect-site concentration) until loss of consciousness and maintained with a BIS value between 40 to 60.
In the remimazolam group, anesthesia is induced with continuous infusion of remimazolam at a rate of 12 mg/kg/hr until loss of consciousness and maintained with a BIS value between 40 to 60.

Outcome(s)

• Primary Outcome: Postoperative nausea attitude,Frequency of vomiting(immediately after the end of anesthesia,2 hours later,24h hours later)
• Secondary Outcome: Whether to use rescue anti-emetics (metoclopramide) The quality of recovery

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude criteria: Under 20 years of age, ASA-PS3 or higher, patient consent not obtained, BMI30 or higher, use of antiemetics within 24h before surgery, taking benzodiazepines, 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