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临床试验/NCT04659057
NCT04659057已完成4 期

Effect of Nebulized Lidocaine, Dexmedetomedine and Their Combination on Haemodynamics During Direct Laryngoscopy Surgery. A Randomized Controlled Clinical Trial.

Ain Shams University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年12月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
180
试验地点
2
主要终点
Diastolic blood pressure

研究概览

简要总结

Direct laryngoscopy (DL) procedure is typically done under general anaesthesia as a day case. It is a short but irritating.Various drugs and drug combinations have been used to attenuate stress response to DL.Administrating nebulized form of drugs can be effective with less systemic side effects. The primary outcome of this study is to compare the effect of premedication with nebulized lidocaine, dexmedetomidine, combination of both to placebo on haemodynamic response during DL procedures.

详细描述

Patients will be transferred to the induction room 30 min prior to surgery. Standard monitors will be applied [pulse oximetry, non invasive blood pressure (NIBP) and electrocardiogram (ECG)]. Basal HR, systolic (SBP), diastolic (DBP) and mean arterial blood pressure (MAP) will be recorded. An intravenous 22-G cannula will be inserted, and all patients will be pre-medicated with intravenous midazolam 0.02 mg/kg, granisetrone 2mg and ranitidine 30 mg.

Patients will then be randomly and evenly allocated to one of 4 groups (45 patients each).

Nebulized solutions will be prepared by a pharmacist not participating in the study. Nebulization will be done with 100% oxygen (10 L/min) through facemask attached to a nebulizer. Patients will be asked to breath normally. Nebulization will continue till the solution in the nebulizer is all aerosolized.

Upon arrival to the operating room, routine monitors will be applied in addition to neuromuscular monitor and end tidal CO2 (ETCO2). General anaesthesia will be induced, after 5 min of preoxygenation, by intravenous fentanyl 1 μg/kg, propofol 1.5-2 mg/kg titrated to a loss of verbal response and rocuronium 1 mg/kg to facilitate endotracheal intubation. Mackintosh laryngoscope will be introduced when train of four (TOF) count reaches 1. High volume-low pressure endotracheal tube (size 5-5.5) will be inserted by senior anaesthesiologist. HR, SBP, DBP and MAP will be recorded immediately after intubation.

Anaesthesia will be maintained by sevoflurane 2-3% in oxygen to air ratio 1:1. Rocuronium 0.1 mg/kg when required. Positive pressure ventilation will be set to maintain ETCO2 30-35 mmHg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

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

入选标准

  • ASA I-III patients admitted for DL surgery.

排除标准

  • Uncontrolled hypertension (MAP > 100 mmHg) or ischaemic heart disease.
  • End stage renal impairment.
  • Chronic drug or alcohol abuse.
  • Predicted difficult airway, laryngoscopy and intubation time > 30 sec, more than one attempt of intubation.
  • Morbid obesity (BMI > 30).
  • Known allergy to the drugs used.

研究组 & 干预措施

Group L

Active Comparator

Lidocaine group; 45 randomly assigned patients.

干预措施: Nebulized Lidocaine (Drug)

Group D

Active Comparator

Demedetomidine group; 45 randomly assigned patients.

干预措施: Nebulized dexmedetomidine (Drug)

Group DL

Active Comparator

Combined lidocaine and dexmedetomidine group. 45 randomly assigned patients.

干预措施: Nebulized lidocaine and dexmedetomidine (Drug)

Group C

Placebo Comparator

Control group; 45 randomly assigned patients.

干预措施: Placebo (Other)

结局指标

主要结局

Diastolic blood pressure

时间窗: Every 5 minutes for 30-60 minutes

Diastolic blood pressure in mmHg

Systolic blood pressure

时间窗: Every 5 minutes for 30-60 minutes

Systolic blood pressure in mmHg

Heart Rate

时间窗: Every 5 minutes for 30-60minutes

Heart rate in beats/min

Mean arterial pressure

时间窗: Every 5 min for 30-60 minutes

Mean arterial pressure in mmHg

次要结局

  • Total fentanyl and esmolol consumption(For 30-60 minutes)
  • recovery time(5- 15 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hala Salah El-Din El-Ozairy, MD

Lecturer of Anaesthesia, ICU and Pain management, Faculty of Medicine, Ain Shams University

Ain Shams University

研究点 (2)

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