The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Presence of Gastric Insufflation
研究概览
简要总结
Aim: Gastric insufflation caused by mask ventilation during laparoscopic surgeries may affect the surgical field, lead to regurgitation of gastric contents, and consequently cause aspiration pneumonia. In this study, we aimed to investigate the effect of preoxygenation instead of mask ventilation in laparoscopic cholecystectomies (LC) on the need for decompression due to gastric insufflation, as well as its impact on postoperative sore throat and the presence of bleeding in aspiration in patients requiring an orogastric (OG) tube.
Materials and Methods: This single-center, prospective, observational study included 128 patients aged 18-65 years with ASA I-III undergoing LC surgery. After anesthesia induction, patients were divided into two groups: those ventilated with a mask (Group A, n=64) and those preoxygenated until their end-tidal oxygen (EtO₂) level exceeded 85% and not ventilated with a mask before induction (Group B, n=64). Anesthesia induction was performed in a standardized manner with appropriate doses for each patient. After administration of a muscle relaxant, patients were intubated by the same anesthesiologist following a 2-minute waiting period. The development of gastric insufflation, the need for OG tube placement, sore throat, and the presence of bleeding in aspiration were compared between the groups.
详细描述
Exclusion criteria for participation in the study:
- Age under 18 or over 65 years,
- Patients who do not wish to participate in the study,
- Patients classified as ASA IV or V,
- History of difficult intubation.
Criteria for termination of study participation:
- Failure to perform endotracheal intubation on the first attempt
- Presence of difficult intubation
- Occurrence of oropharyngeal or laryngeal trauma during intubation
Expected Benefits and Risks of the Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
- •Patients aged 18-65 years
- •ASA physical status I, II, or III
排除标准
- •Patients younger than 18 years or older than 65 years
- •ASA physical status IV or V
- •History of difficult intubation
- •Termination Criteria:
- •Failure to achieve successful intubation on the first attempt
- •Difficult intubation during the procedure
- •Oropharyngeal or laryngeal trauma occurring during endotracheal intubation
结局指标
主要结局
Presence of Gastric Insufflation
时间窗: Immediately after creation of pneumoperitoneum
The surgeon assessed the degree of gastric distension after trocar placement and creation of pneumoperitoneum with CO₂. If gastric insufflation was present, an orogastric (OG) tube was inserted in both groups.
次要结局
- Severity of Postoperative Sore Throat(Postoperative 10 minutes)
- Presence of Blood During Suction at Extubation(During extubation)
- Postoperative presence of a blood smell in the mouth(Postoperative 10 minutes)