Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery Under Sevoflurane Anesthesia: A Randomized Double-blind Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Incidence of emergence agitation
研究概览
简要总结
Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression.
This randomized, double-blind, non-inferiority trial will compare low-dose remimazolam (0.03 mg/kg) with the standard dose (0.1 mg/kg) administered at the end of surgery in adult patients undergoing nasal surgery under sevoflurane anesthesia. The primary objective is to determine whether low-dose remimazolam is non-inferior to the standard dose in preventing emergence agitation. Secondary outcomes include burst suppression, recovery profiles, and safety outcomes.
详细描述
Emergence agitation (EA) is characterized by confusion, agitation, and non-purposeful movements during recovery from general anesthesia. In adult patients undergoing nasal surgery with sevoflurane anesthesia, EA occurs frequently and may result in self-injury, accidental removal of medical devices, postoperative bleeding, prolonged recovery, and increased healthcare burden.
Remimazolam is an ultra-short-acting benzodiazepine that is rapidly metabolized by tissue esterases and can be antagonized with flumazenil. Previous studies have demonstrated that intravenous administration of remimazolam 0.1 mg/kg at the end of surgery reduces the incidence of EA after nasal surgery. However, this dose may produce deeper-than-necessary sedation and increase the occurrence of burst suppression, which has been associated with postoperative delirium.
The present study aims to evaluate whether a lower dose of remimazolam (0.03 mg/kg), corresponding to the supplemental dose commonly used for procedural sedation, can preserve the preventive effect on EA while reducing excessive electroencephalographic suppression and improving recovery characteristics.
This is a prospective, randomized, double-blind, non-inferiority trial conducted at Jeju National University Hospital. Adult patients scheduled for nasal surgery under sevoflurane anesthesia will be randomly assigned in a 1:1 ratio to receive either remimazolam 0.03 mg/kg or remimazolam 0.1 mg/kg immediately after discontinuation of sevoflurane at the end of surgery.
The primary outcome is the incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater. Secondary outcomes include the incidence and duration of burst suppression assessed using the SedLine monitor, Patient State Index (PSi), extubation time, post-anesthesia care unit (PACU) length of stay, and safety outcomes including hypoxemia, hypotension, flumazenil administration, and other adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 79 years.
- •Scheduled to undergo elective nasal surgery under sevoflurane-based general anesthesia at Jeju National University Hospital.
- •Able to provide written informed consent.
排除标准
- •Contraindications to remimazolam.
- •History of allergy or hypersensitivity to benzodiazepines.
- •Inability to provide informed consent due to cognitive impairment.
- •Preexisting psychiatric disorders.
- •History of alcohol or substance abuse.
- •Inability to assess the Riker Sedation-Agitation Scale (SAS).
- •Body mass index (BMI) > 40 kg/m².
研究组 & 干预措施
Standard-dose Remimazolam
Participants will receive remimazolam 0.1 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia.
干预措施: Remimazolam (Drug)
Low-dose Remimazolam
Participants will receive remimazolam 0.03 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia.
干预措施: Remimazolam (Drug)
结局指标
主要结局
Incidence of emergence agitation
时间窗: Within 15 minutes after extubation
The incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater.
次要结局
- Incidence of burst suppression(From study drug administration until extubation(up to 30 minutes))
- Duration of burst suppression(From study drug administration until extubation(up to 30 minutes))
- Lowest Patient State Index (PSI)(From study drug administration until extubation(up to 30 minutes))
研究者
Seung Eun Song
Assistant Professor, Department of Anesthesiology
Jeju National University School of Medicine