Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changing in mean arterial pressure (MAP) during the peri-intubation period
研究概览
简要总结
The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique.
The main question it aims to answer is:
- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?
Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.
详细描述
Anesthetic protocol
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Preoperative
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After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.
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No preoperative sedatives or analgesics were administered.
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Intraoperative Pre-induction phase
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Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.
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BIS (Bispectral index) was monitored
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Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.
Intervention: prepared before induction anesthesia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years old
- •American Society of Anesthesiologists (ASA) physical status classification I-II
排除标准
- •History of lidocaine allergy
- •Predicted difficult airways
- •Body mass index > 35 kilograms per meter squared
- •Risk aspiration
- •Baseline hemodynamic instability; heart rate < 50 bpm, heart rate > 120 bpm, blood pressure < 90/60 mmHg, blood pressure > 160/90 mmHg
- •Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease
- •Cerebral aneurysm, Arteriovenous malformation, Tumor size > 4 centimeters, Brain herniation
研究组 & 干预措施
Group SL
10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each.
干预措施: lidocaine spray (Drug)
Group IL
2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.
干预措施: Intravenous Lidocaine (Drug)
结局指标
主要结局
Changing in mean arterial pressure (MAP) during the peri-intubation period
时间窗: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Mean arterial pressure was recorded in mmHg by the anesthesiologist
Changing in blood pressure (BP) during the peri-intubation period
时间窗: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Blood pressure was recorded in mmHg by the anesthesiologist
Changing in heart rate (HR) during the peri-intubation period
时间窗: T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation
Heart rate was recorded in bpm by the anesthesiologist
次要结局
- Incidence of adverse event during laryngoscopy and intubation procedure(During laryngoscopy and intubation procedure)
研究者
Nattawadee Phokaw, MD
Principal investigator
Khon Kaen University