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临床试验/NCT06040034
NCT06040034已完成2 期

Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients

Universitas Padjadjaran1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Post-Extubation Cough Grade

研究概览

简要总结

The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:

  • Cough incidence on both groups
  • Which method is preferable to reduce post-extubation cough incidence

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, Care Provider)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class 1 and 2
  • Thyroidectomy patients in Hasan Sadikin Bandung Hospital

排除标准

  • Subjects' refusal
  • Had history of drug allergy, specifically lidaocaine
  • Had history of asthma or other lung diseases
  • Active smoker
  • History of arrhythmia
  • Bradycardia subjects (<60 beats per minute)
  • Pregnant people
  • Perioperative upper respiratory tract infusion
  • Routinely consume ACE inhibitor / bronchodilators / steroid
  • Renal dysfunction
  • Liver dysfunction

研究组 & 干预措施

Continuous Lidocaine Intravenous Infusion

Active Comparator

Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe.

干预措施: Lidocaine IV (Drug)

Bolus Lidocaine Intravenous

Active Comparator

Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump.

干预措施: Lidocaine IV (Drug)

结局指标

主要结局

Post-Extubation Cough Grade

时间窗: 24 hours post operative

Cough graded according to the following criteria: Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, \>1 cough lasting \<5 seconds; Grade 3: coughing heavily and continuously for \>5 seconds)

次要结局

  • Number of participant experiencing tachycardia(24 hours perioperative)
  • Number of participant experiencing hypertension(24 hours perioperative)
  • Number of participant experiencing hypotension(24 hours perioperative)
  • Number of participant experiencing bradycardia(24 hours perioperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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