The Effects of Pharyngeal Packing on the Postoperative Gastric Fluid Volume Measured by Ultrasound in Patients Undergoing Functional Endoscopic Nasal Surgery, a Randomized Controlled Double-blinded Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- The primary outcome of the current study is Gastric residual volume at the end of the procedure.
研究概览
简要总结
In this study, the aim is to investigate the effects of Pharyngeal Packing on the perioperative gastric volume in patients undergoing FESS, by ultrasound assessment
详细描述
Following approval from the Ethics and Research Committee of the anesthesia department, Faculty of Medicine, Cairo University, and obtaining written informed consent from all participating patients meeting the inclusion criteria; patients will be randomly assigned into two groups using a computer-generated random number list with a closed-sealed envelope.
- Group (P): will include the patients who will receive pharyngeal packing
- Group (C): will include the patients who will not receive pharyngeal packing The day before the operation, all patients should be instructed to follow institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food) On operation day,The patient will attend at the pre-anesthesia room 1 hour before the procedure. A 20 Gauge cannula will be inserted peripherally.
Prophylactic antiemetic (metoclopramide 0.15mg/ kg) will be given slowly intravenously as premedication.
Then a serial ultrasonographic qualitative and quantitative assessment of the gastric antrum of the patients will be done and recorded preoperatively by the anesthetist who will be blinded to the study groups.
A preoperative ultrasonographic examination of the gastric antrum (at the sagittal plane between the left lobe of the liver and pancreas at the level of the aorta) will be performed in the right lateral decubitus position
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be adult patients (above 18 years), with American Society of Anesthesiologists physical status I-II, scheduled for elective FESS under general anesthesia.
排除标准
- •Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM).
- •Pregnancy.
- •Body mass index (BMI) greater than 35 kg/m
- •Refusal of the patient.
研究组 & 干预措施
non packing group (c)
will include the patients who will not receive pharyngeal packing
干预措施: Nasal packing (Procedure)
packing group (P)
will include the patients who will receive pharyngeal packing
干预措施: Nasal packing (Procedure)
结局指标
主要结局
The primary outcome of the current study is Gastric residual volume at the end of the procedure.
时间窗: 4 hours
The primary outcome of the current study is Gastric residual volume at the end of the procedure.
次要结局
- Quantitative assessment of the risk of aspiration(6 hours)
- Post operative nausea and vomiting incidence at PACU(6 hours)
- Lung ultrasound Score(6 hours)
- Throat pain at Post anesthesia care unit(6 hours)
研究者
Khaled Abdelfattah Abdallah Sarhan
principal investigator, Asst. professor of anesthesia, Cairo university
Kasr El Aini Hospital