Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Degree of hoarseness 1 hour after extubation
研究概览
简要总结
Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures.
详细描述
In general anesthesia, it is neccessary to secure the airways with an endotracheal tube. There is no international consensus on how intubation is most efficiently conducted. A cochrane review compared using muscular relaxing medication versus not using blocks for intubation. Primary outcomes were intubation conditions and discomfort in upper airways. The authors concluded that research is limited, and that further research is needed. No studies have compared local anesthetic spray on the glottis and muscular relaxing medication in intubation, focusing on discomfort in upper airways. The null-hypothesis of this study is that there is no difference in upper airway discomfort when using local anesthetic spray or muscular relaxing medication. The study will have a randomized controlled design, randomizing patients undergoing gastro- or gynecological procedures in general anesthesia to receiving either rocuronium (muscle relaxing medication) intravenous, or lidocain spray on the glottis before intubation. The primary outcome is postoperativ hoarseness one hour after intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
A study nurse will prepare sealed envelopes with the study-arm specified inside. Patients fullfilling the inclusion criteria will be invited to participate. Patients will be blinded for study arm. Intubation will be performed by trained intubators. However, due to the medications possible risk for rest-curarisation, the anesthesia personnel will possibly be able to detect intervention. However, care personnel collecting data will not know which study arm the patient belongs to.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA (American Association of Anesthesiologists Classification system for physical status) I-III
- •Understand and can express themselves in Norwegian
- •Able to give informed consent to participate
排除标准
- •Cave lidocain and/or muscle relaxing medication
- •BMI above 40
- •Anticipated difficult intubation
- •Need for ventricular tube
- •Pathology or malformations in upper airways
研究组 & 干预措施
Lidocaine spray on the glottis
Lidocaine 20 mgl/ml- 4,4 ml will be sprayed on the glottis. Ventilation for 90 sek, intubation
干预措施: Lidocaine topical (Drug)
Muscle relaxing medication
Rocuronium 0,6 mg/kg administered intravenous. Ventilation for 2.5 minutes (150seconds), intubation
干预措施: Lidocaine topical (Drug)
结局指标
主要结局
Degree of hoarseness 1 hour after extubation
时间窗: 1 hours
Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia
次要结局
- Proportion of patients who cough on tube at extubation(At extubation)
- Number of patients needing extra equipment for intubating(At intubation)
- Proportion of patients who cough when spraying(At intubation)
- Intubation conditions(Before intubation)
- Number of intubation attempts(At intubation)
- Proportion of patients with normal anatomy in upper airways(At intubation)
- Heart rate changes during intubation(at intubation)
- Proportion of patients with blood on tube after extubation(At extubation)
- Blood pressure changes during intubation(at intubation)
- Degree of hoarsness 24 and 48 hours after extubation(2-48 hours)
- Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation(2-48 hours)
研究者
Ann-Chatrin Leonardsen
Professor
Ostfold Hospital Trust