Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Severity of Airway Interruption
研究概览
简要总结
Primary Objective:
- To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.
详细描述
Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air. This numbness in the throat should stop the urge to clear the throat in the middle of the operation. Therefore, this should stop the interruptions during the surgery.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Participants in Group 1 will receive the saline mist. This will moisturize and soothe the throat. Participants in Group 2 will receive the lidocaine mist. Lidocaine or saline is misted into the air that you breathe during the surgery. You and your surgeon will not be told which group you were assigned to. At the end of the surgery, your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial.
You will be considered off-study once you are sent to the recovery room after surgery.
This is an investigational study. Lidocaine is FDA-approved and commercially available for local anesthesia. If you are in the lidocaine or the saline group. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.
排除标准
- •Patients who are excluded will be any who require elective endotracheal intubation as a preoperative decision by the anesthesia team. These patients will be those with sleep apnea, BMI>35, uncontrolled gastro esophageal reflux.
- •Patients who have a history of allergy/hypersensitivity to lidocaine.
研究组 & 干预措施
Saline
Saline misted into the air breathe during the surgery.
干预措施: Saline (Drug)
Lidocaine
Lidocaine misted into the air during the surgery.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Severity of Airway Interruption
时间窗: Assessment made by surgeon during minimally invasive parathyroidectomy surgery
Quality of Operative Field
时间窗: Assessment made by surgeon during minimally invasive parathyroidectomy surgery
次要结局
未报告次要终点