The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia: A Prospective Randomized Double-blinded Control Study
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Occurrence of respiratory complications
研究概览
简要总结
The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on respiratory events during a less than 2-hour elective surgery.
详细描述
Laryngeal Mask Airway (LMA) anesthesia is generally performed for ambulatory surgery to avoid the use of neuromuscular blocking agents and to facilitate rapid emergence from anesthesia. Inhaled anesthetics are simply and popularly used during maintenance of anesthesia. The two most recent volatile anesthetic agents, desflurane and sevoflurane, are the two most commonly used in clinical practice for an ambulatory setting.
Desflurane is the volatile agent with low blood: gas partition coefficient (0.42). Desflurane's uptake and elimination from the body of a patient are rapid, which results in a fast onset of anesthesia and a fast recovery from anesthesia. This property provides desflurane as an ideal agent for the ambulatory anesthesia. However, its pungent odor is concerned to irritate the upper airway and may cause significant respiratory complications. Sevoflurane has a blood: gas partition coefficient of 0.65, which is slightly greater than desflurane. The major advantage over desflurane is the better scent. It is considered to be less airway irritation in LMA anesthesia with smooth induction and recovery.
The limitation of desflurane on its odor leads to a controversy if desflurane is similar to or worse than sevoflurane for LMA anesthesia. This is non-inferiority study designed to compare the occurrence of respiratory complications between desflurane and sevoflurane during LMA anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with gastroesophageal reflux disease
- •Patients with hiatal hernia
- •Patients with history of upper respiratory tract infection within 1 month before surgery
- •Heavy smoker (> 20 cigarettes per day)
- •Obese patients with body mass index > 30kg/m2
- •Pregnant patients
- •Unable to provide a written informed consent patients
- •Surgery requiring non-depolarizing muscle relaxants
研究组 & 干预措施
Desflurane
Desflurane group: The rule of 24 will be applied, which means that the fresh gas flow (l/ min) multiplied by volume percent of desflurane must not exceed 24. Therefore, once the patients return of spontaneous ventilation, an anesthesiologist turns on oxygen 1 l/ min, nitrous oxide 1 l/ min, and desflurane 12 vol% for 1-2 minutes. When the end-tidal desflurane reaches 3-3.5% (approximately 0.5 MAC), the anesthesiologist will decrease oxygen and nitrous oxide to each 0.5 l/ min and desflurane to 6 vol% (1 MAC). Desflurane concentration will be adjusted to maintain the end-tidal desflurane around 3-6% (0.5-1 MAC).
干预措施: Desflurane (Drug)
Sevoflurane
Sevoflurane group: The oxygen and nitrous oxide each 1 l/min will be turned on with sevoflurane 4 vol% for 1-2 minutes or until the end-tidal sevoflurane reach 1-1.2% (approximately 0.5 MAC). After that, the flow of oxygen and nitrous oxide is reduced to each 0.5 l/ min and concentration dial of sevoflurane is set to 2 vol% (1 MAC). During the operation, sevoflurane concentration will be adjusted to maintain the end-tidal sevoflurane around 1-2% (0.5-1 MAC)
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Occurrence of respiratory complications
时间窗: From the beginning of operation until 30 minutes after the operation
Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation
次要结局
- Time to follow motor command(Within 30 minutes after the end of operation)
- Frequency of postoperative nausea and vomiting (PONV)(Within 2 hours after operation)
- Time of eye opening(Within 30 minutes after the end of operation)
- Time of LMA removal(Within 30 minutes after the end of operation)
- Changes of blood pressure during anesthesia(Every 15 minutes, from the beginning of operation until 30 minutes after the operation)
- Changes of heart rate during anesthesia(Every 15 minutes, from the beginning of operation until 30 minutes after the operation)
研究者
Pathomporn Pin on, M.D.
Associate Professor
Chiang Mai University