Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant; Impact on Postoperative Sore Throat and Haemodynamics
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sore Throat postoperative. Assessment of complaints and changes in complaints
研究概览
简要总结
When a surgical procedure is performed under general anesthesia, the Airways are often secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies have shown a reduction of these side effects when by use of muscle relaxants or a lidocain spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the two methods or nothing. These methods will be studied systematically.
Heart rate and blood pressure rise during the intubation procedure. The investigators will also study the differences between the groups.
详细描述
Post-operative sore throat and cough are common complications of endotracheal intubation and occurs in 30% to 70% of patients. Spraying with Lidocaine reduces this incident of postoperative sore Throat (POST). The use of neuromuscular blocking agents (NMBA) alone will also diminish the incidence of adverse postoperative upper airway symptoms. The use of topical Lidocaine is shown to reduce the cardiovascular responses during and after endotracheal intubation.
Hypertension and tachycardia as a response to endotracheal intubation are probably of little consequence in healthy individuals. These reactions might though be harmful in patients with cardiovascular diseases.
Postoperative sore throat is an undesired outcome for the patient. Topical or systemic pharmacological interventions is shown to reduce the POST.
Our anesthetists practice very different. The investigators sometime use topical lidocaine 2% as a spray, sometime muscle relaxants and often nothing but propofol and remifentanil prior to laryngoscopy an endotracheal intubation.
The objective of this study is to determine, whether the use of topical administered lidocaine, 2 %, has a better impact on POST compared with NMBA alone in general anesthesia with propofol and remifentanil. Patients receiving nothing but propofol and remifentanil will be the reference group. Assessment of the intubation conditions will be done according to a standard scheme
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
- Double (Investigator, Outcomes Assessor)
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
- •Scheduled elective surgery with general anesthesia and planned endotracheal intubation.
排除标准
- •20>BMI<35
- •Allergy to local anesthetics or neuromuscular blocking agents.
- •The ASA physical status classification system is a system for assessing the fitness of patients before surgery. BMI is Body Mass Index measured in kilograms/square meter.
研究组 & 干预措施
Lidocaine spray
Endotracheal lidocaine spray prior to intubation
干预措施: Lidocaine spray (2%) (Drug)
Muscle relaxant
Muscle relaxant prior to intubation
干预措施: Muscle Relaxant (Rocuronium) (Drug)
No Muscle relaxant, no Lidocaine
'No Muscle relaxant, no Lidocaine Control group
干预措施: No Muscle relaxant, no Lidocaine (Other)
结局指标
主要结局
Sore Throat postoperative. Assessment of complaints and changes in complaints
时间窗: 2 h and 24 h after extubation
Postoperative sore throat, described 2 h and 24 h after extubation. If the patient has sore throat or is hoarse, the complaint is assessed on a VAS (Visual Analogue Scale) 1 - 10.
Hemodynamic parameters, change in HR (Heart Rate) is being assessed
时间窗: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.)
Describes changes in HR (Heart Rate)
Intubation conditions directly after induction of anesthesia
时间窗: 90 sec. after established general anesthesia
Describes the intubation conditions: Jaw relaxation, resistance to laryngoscopy blade, the position and movement of vocal cords, the movement of limbs and coughing. Each variable rates as excellent, good or poor. Intubation conditions are many variables described once and should not be divided into several outcomes.
Hemodynamic parameters, change in BP (blood pressure) is being assessed
时间窗: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.)
Describes changes in BP(Blood Pressure)
次要结局
未报告次要终点
研究者
Jan Sverre Vamnes
Senior consultant, Ph.D.
Ostfold Hospital Trust