IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Successful completion of the operation
研究概览
简要总结
Objective: To determine the effectiveness and safety of IV sedation combined with ultrasound-guided, left side transversus abdominis plane (TAP) block versus combination with local anesthetic (LA) infiltration for Percutaneous Endoscopic Gastrostomy (PEG) tube placement.
Background: The procedure used to be done with general anesthesia or IV sedation with LA infiltration, but the use of IV sedation with TAP block may be another option.
Patients and Methods: This was a prospective randomized study including 60 patients, requiring long-term nutritional support, underwent the PEG procedure at the GIT endoscopy unit at our Hospital. Patients were randomly allocated into two equal groups, in group A; procedures were performed with IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block, while in group B; procedures were performed with IV midazolam and propofol-based sedation with LA infiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring long-term nutritional support
- •American Society of Anesthesiologists (ASA) physical status II-III
- •Age ≥ 6 years
排除标准
- •American Society of Anesthesiologists (ASA) physical status > III
- •Patients younger than 6 years
- •Previous PEG placement
- •Allergy to local anesthetics
- •Patient refusal
结局指标
主要结局
Successful completion of the operation
时间窗: 20 minutes after introducing the endoscope in the patient mouth
Successful placement of percutaneous endoscopic gastrostomy Tube
次要结局
- Mean and Standard deviation of Heart Rate (beat/minute)(mean±SD)(30 minutes after patients entered the endoscopy room)
- Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)(30 minutes after patients entered the endoscopy room)
- Mean and Standard deviation of Oxygen Saturation (SpO2) (%)(mean±SD)(30 minutes after patients entered the endoscopy room)
- Number of participants and Rate of Patients' Satisfaction of the service(48 hours after entering the endoscopy unit)
- Number of participants and Rate of Anesthesia-related Complications(24 hours after the end of operation)
- Median and Range of Numeric Pain Rating Scale (NPRS)(24 hours after the end of operation)
- Mean and Standard deviation of Hospital stay duration (hour)(mean±SD)(48 hours after entering the endoscopy unit)