Laparoscopic Cholecystectomy Patients: Effect of Sevoflurane vs. Desflurane on Mechanical Power - A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Mechanical Power (MP) during General Anesthesia
研究概览
简要总结
This single-center, prospective, randomized, assessor-blinded clinical trial aims to compare the effects of sevoflurane and desflurane anesthesia on intraoperative mechanical power in adult patients undergoing elective laparoscopic cholecystectomy. Mechanical power will be measured at three standardized time points using a validated formula, and secondary outcomes include driving pressure values and early postoperative respiratory complications (desaturation, laryngospasm, bronchospasm, cough).
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
- Single (Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors are masked to group allocation. The anesthesia team administering sevoflurane or desflurane is not blinded, but all intraoperative data collectors and postoperative evaluators remain blinded to the inhalational agent used. Randomization is performed using sealed opaque envelopes to maintain allocation concealment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •ASA Physical Status I-II
- •Scheduled for elective laparoscopic cholecystectomy
- •Able to provide written informed consent
排除标准
- •Known hypersensitivity or contraindication to study medications (sevoflurane or desflurane)
- •Severe chronic obstructive pulmonary disease (COPD)
- •Uncontrolled bronchial asthma
- •Decompensated heart failure (NYHA Class III-IV)
- •History of prior lung surgery
- •Morbid obesity (BMI > 35 kg/m²)
- •Refusal to participate or inability to provide informed consent
研究组 & 干预措施
Arm D-desflurane group
Maintenance of general anesthesia with desflurane 6% during laparoscopic cholecystectomy. Mechanical power is measured at three standardized intraoperative time points under identical ventilator settings.
干预措施: Desflurane (Drug)
Arm S- Sevoflurane Group
Maintenance of general anesthesia with sevoflurane 2% during laparoscopic cholecystectomy. Mechanical power is measured at three intraoperative time points using standardized ventilator settings.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Mechanical Power (MP) during General Anesthesia
时间窗: Measured at three intraoperative time points: Post-intubation baseline (MP1) 15 minutes after pneumoperitoneum (MP2) End of surgery before emergence (MP3)
Mechanical Power (MP) during General Anesthesia
时间窗: Measured at three intraoperative time points: Post-intubation baseline (MP1) 15 minutes after pneumoperitoneum (MP2) End of surgery before emergence (MP3)
次要结局
未报告次要终点
研究者
Nuran Akıncı Ekinci
Specialist in Anesthesiology and Reanimation
Konya City Hospital