The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.
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
- Cough reflex.
研究概览
简要总结
Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Lidocaine administration has been widely used for reducing cough during extubation due to its simplicity and lack of serious adverse effects; There are two major routes for lidocaine administration systemic intravenous injection and local direct application on the laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective adrenoceptor agonist and the most characteristic features include sympatholytic sedation analgesia and lack of respiratory depression. The aim of this study is to compare the effect of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.
详细描述
The patients were randomly allocated into three groups each containing (40) patient. Group D received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down the intratracheal tube of patients.
The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times, preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation time, the incidence of complications due to increasing IOP and surgeon satisfaction
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged from 18 to 60 years old
- •ASA I or II class
- •Undergo elective intraocular surgery
- •Under general anesthesia.
排除标准
- •Renal impairment
- •Cardiorespiratory abnormalities
- •Bronchial asthma COPD
- •Restrictive lung diseases
- •Liver failure
- •Allergy to drugs will be used
- •Patient refuse
- •Pregnancy-lactation
- •Significant obesity
研究组 & 干预措施
control
At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients.
干预措施: intratracheal saline (Drug)
Dexmedetomidine
At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients
干预措施: intratracheal Dexmedetomidine (Drug)
Lidocaine
At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
干预措施: intratracheal Lidocaine (Drug)
结局指标
主要结局
Cough reflex.
时间窗: from time of awareness to 5 minute after extubation
To evaluate efficacy and safety of both dexmedetomidine and lidocaine on Cough: from time of awareness to 5 minute after extubation 0= no cough 1. minimal Cough (single) 2. moderate cough\<= 5S 3. severe cough \>=5S (bucking)
次要结局
- mean arterial blood pressure(before anesthesia up to 30 minute after extubation)
- heart rate(before anesthesia up to 30 minute after extubation)
研究者
haidy salah mansour
Assistant professor in of Anesthesia and Intensive Care units in Minia University hospital
Minia University