Incidence of Mucosal Injury Using Pharyngeal Packing in Surgery of the Nasal Sinuses
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Incidence and severity of mucosal injury
研究概览
简要总结
After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
详细描述
Aim of the study
Post-operative nausea and vomiting (PONV) is a complication of anaesthesia and responsible for malaise of surgical patients. Furthermore, PONV has been shown causing additive costs due to anti-emetic drugs and prolonged hospitalisation. The occurrence of PONV is multifactorial. Beside individual patients factors, opioid use and type of surgery seem to be responsible for occurrence of PONV. Especially, sinus surgery carries a high risk of PONV. Blood from the operation site entering the stomach has been discussed the potential cause for PONV in this specific patient population.
Therefore, hypopharyngeal packing following orotracheal intubation is a common clinical practice to prevent blood passing through the esophagus and so to lower the incidence of PONV.
Unfortunately, there are limited data data supporting the effectiveness of this procedure. In contrast, some references suggest that hypopharyngeal packing may be associated with postoperative mucosal injury and sore throat with high impact on patients´ well-being.
To evaluate the usefulness and safety of hypopharyngeal packing the investigators perform prospective randomized study with the following objective:
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
- Single (Participant)
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
- •Surgery of the sinuses
- •Patients over 18 years of age
- •Duration of surgery > 1h
排除标准
- •Refusal of the patient
- •Patients under 18 years of age
- •Chemotherapy with antiemetic medication
- •Combined surgery (for example tonsillectomie and sinus surgery)
- •Pregnancy
研究组 & 干预措施
Hypopharyngeal packing
Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups.
After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
干预措施: Hypopharyngeal packing (Device)
Without hypopharyngeal packing
Patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups.
After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.
干预措施: Without Hypopharyngeal packing (Device)
结局指标
主要结局
Incidence and severity of mucosal injury
时间窗: Second postoperative day
Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management
次要结局
未报告次要终点
研究者
Saskia Jetten
P.D. Dr. med. M. Beiderlinden
Marienhospital Osnabrück