Impact of Site of Tracheal Extubation on Operating Room Efficiency During Robot-assisted Surgery: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Operating room (OR) occupancy time
研究概览
简要总结
This study aims to evaluate the impact of different extubation strategy on the occupancy time of operating room (OR) and the incidence of adverse events and quality of recovery after robotic-assisted surgery. The investigators hypothesize that extubation in the post-anesthesia care unit (PACU) may reduce OR occupancy time without increasing adverse events or worsening quality of recovery early after robotic-assisted surgery. This strategy may enhance perioperative efficiency while maintaining clinical safety.
详细描述
Major surgeries are generally performed under general anesthesia with endotracheal tube. Intubation during anesthesia induction and extubation during anesthesia emergence are two high-risk periods associated with anesthesia-related complications. In clinical practice, extubation is performed either in the OR or in the PACU, according to local routine.
Robotic-assisted surgery offers potential clinical benefits but involves high costs and limited resource availability, making operating room (OR) efficiency a critical priority. While extubation in the post-anesthesia care unit (PACU) has been suggested to improve OR turnover, evidence regarding its impact on perioperative efficiency and safety compared to standard OR extubation in robotic surgery is limited.
The investigators hypothesize that extubation in the post-anesthesia care unit (PACU) may reduce OR occupancy time without increasing adverse events or worsening quality of recovery early after robotic-assisted surgery. This study aims to evaluate the impact of different extubation strategy on the occupancy time of operating room (OR) and the incidence of adverse events and quality of recovery after robotic-assisted surgery.
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 (Investigator, Outcomes Assessor)
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
- •Aged ≥18 years;
- •Scheduled to undergo elective robot-assisted laparoscopic surgery under general anesthesia;
- •Expected tracheal extubation during daytime working hours (before 4:00 PM).
排除标准
- •Refuse to participate in the study;
- •Morbid obesity (body mass index ≥35 kg/m²);
- •Preoperatively diagnosed obstructive sleep apnea, or patients with a STOP-Bang score ≥3 in combination with serum bicarbonate (HCO₃-) ≥28 mmol/L;
- •Patients at high risk of difficult airway (anticipated difficult intubation and/or extubation during preoperative assessment);
- •Preexisting sick sinus syndrome, severe sinus bradycardia (heart rate < 50 beats/min), or second-degree or higher atrioventricular block without pacemaker implantation; congenital heart disease with any type of arrhythmia; or other severe cardiovascular diseases with New York Heart Association (NYHA) functional class ≥III;
- •Significant pulmonary function impairment (FEV₁/FVC ratio < 70%, and total lung capacity [TLC] and vital capacity [VC] < 80% of predicted values);
- •Severe hepatic dysfunction (Child-Pugh class C); severe renal dysfunction (estimated glomerular filtration rate < 30 mL/min/1.73 m²); or American Society of Anesthesiologists (ASA) physical status classification ≥IV;
- •Preoperative diagnoses of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
- •Inability to communicate due to coma, severe dementia, or language impairment;
- •Planned postoperative admission to the intensive care unit;
- •Any other conditions that are deemed for study participation.
研究组 & 干预措施
Extubation in post-anesthesia care unit (PACU)
At the end of surgery, patients will be transferred from operating room (OR) to PACU with endotracheal intubation and then extubated in PACU.
干预措施: Extubation in post-anesthesia care unit (PACU) (Procedure)
Extubation in operating room (OR)
At the end of surgery, patients will be extubated in operating room (OR) and then transfered to PACU.
干预措施: Extubation in operating room (OR) (Procedure)
结局指标
主要结局
Operating room (OR) occupancy time
时间窗: Up to 2 hours after surgery
Time interval from end of surgery to leaving OR for PACU.
次要结局
- Incidence of emergence delirium(Up to 3 hours after surgery)
- Incidence of adverse events before leaving PACU(Up to 3 hours after surgery)
- Time interval from end of surgery to modified Aldrete score of ≥9(Up to 3 hours after surgery)
- Time interval from end of surgery to PACU discharge(Up to 2 hours after surgery)
研究者
Dong-Xin Wang
Chief Physician, Professor
Peking University First Hospital