Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Extubation Time
研究概览
简要总结
This randomized, parallel-group, non-inferiority clinical trial aims to evaluate whether an anesthetic swap strategy consisting of sevoflurane followed by desflurane 30 minutes before the end of surgery is non-inferior to continuous desflurane anesthesia with respect to extubation time in adults undergoing elective laparoscopic bariatric surgery. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8, incidence of postoperative nausea and vomiting, post-anesthesia care unit length of stay, and desflurane-related costs.
详细描述
Obesity is associated with an increased risk of postoperative respiratory complications, making rapid and safe anesthetic recovery particularly important in patients undergoing bariatric surgery. Desflurane provides rapid emergence because of its favorable pharmacokinetic profile but is associated with higher cost and greater environmental impact than sevoflurane.
This prospective, randomized, parallel-group, non-inferiority trial will compare two inhalational anesthetic strategies in adults undergoing elective laparoscopic bariatric surgery at Clínica Dávila. Participants will be randomly assigned in a 1:1 ratio to receive either continuous desflurane throughout the procedure or a swap strategy consisting of sevoflurane during most of the operation followed by desflurane beginning 30 minutes before surgical closure.
The primary outcome is extubation time, defined as the interval from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8 in the post-anesthesia care unit, incidence of postoperative nausea and vomiting, length of stay in the post-anesthesia care unit, and desflurane-related costs. The study is designed to determine whether the swap anesthetic strategy is non-inferior to continuous desflurane while reducing desflurane consumption, with potential benefits for environmental sustainability and healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors are blinded to treatment allocation. The anesthesiologist administering the intervention is not blinded because of the nature of the anesthetic techniques
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Scheduled for elective laparoscopic gastric bypass surgery.
- •Body mass index between 30 and 50 kg/m².
- •American Society of Anesthesiologists physical status II or III.
- •Able and willing to provide written informed consent.
排除标准
- •Surgical procedure lasting less than 2 hours.
- •Body mass index greater than 50 kg/m².
- •Significant cardiac disease.
- •Moderate or severe obstructive respiratory disease, including uncontrolled asthma or chronic obstructive pulmonary disease.
- •Pregnancy or breastfeeding.
- •Known allergy or contraindication to medications used during the intraoperative period.
- •Personal or family history of malignant hyperthermia.
- •Active illicit drug use or substance dependence.
- •Advanced chronic kidney disease, defined as an estimated glomerular filtration rate below 60 mL/min.
- •Myasthenia gravis or another neuromuscular junction disorder.
- •Severe cognitive or psychiatric disorder.
- •Refusal to participate or withdrawal of informed consent at any time.
研究组 & 干预措施
Sevoflurane-Desflurane Swap
Participants receive sevoflurane during most of the procedure and are switched to desflurane 30 minutes before the end of surgery according to the study protocol.
干预措施: Sevoflurane-Desflurane (Drug)
Continuous Desflurane
Participants receive desflurane as the inhalational anesthetic throughout the entire elective laparoscopic bariatric surgery according to the study protocol.
干预措施: Desflurane (Drug)
结局指标
主要结局
Extubation Time
时间窗: Perioperative
Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.
次要结局
- Time to Achieve Patient State Index Greater Than 80(Perioperative)
- Postoperative Nausea and Vomiting(Up to 24 hours after surgery)
- Time to Achieve an Aldrete Score of at Least 8(Up to 24 hours after surgery)
- Time to Post-Anesthesia Care Unit Discharge Readiness(Up to 24 hours after surgery)
- Desflurane-Related Cost(Periprocedural (during surgery))