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临床试验/NCT07154628
NCT07154628尚未招募4 期

Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
post-intubation hypertension

研究概览

简要总结

Endotracheal intubation is a respiratory management technique used during general anesthesia. It is essential for certain surgical procedures as it ensures a secure airway for the patient.

However, during the placement of the endotracheal tube, the passage of the tube through the vocal cords can cause pain stimulation, leading to an increase in heart rate and blood pressure. Lidocaine reversibly blocks the conduction of nerve impulses along nerve fibers by preventing the movement of sodium ions across the nerve membrane. Topical application of lidocaine near the vocal cords before endotracheal tube placement may be a way to reduce the surgical pleth index and changes in vital signs (heart rate, blood pressure) caused by excessive endotracheal tube stimulation.

This study aims to investigate the benefit of topical spraying of lidocaine on the vocal cords before endotracheal tube placement during routine da Vinci surgery. The primary outcomes were the pharmacological effects of spraying either lidocaine or normal saline (control group) on the vocal cords. These included: post-intubation hypertension (defined as an increase in systolic blood pressure of more than 20% from baseline), changes in mean arterial pressure before and after intubation, and objective pain indices such as the Surgical Pleth Index. Secondary outcomes included post-intubation hypotension (defined as mean arterial pressure less than 70 mmHg), as well as postoperative complaints and severity of sore throat, pain on swallowing, and hoarseness.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA classification I~III
  • aged 18~69 y/o
  • BMI 18~35 kg/m2
  • scheduled for elective robotic surgery under general anesthesia

排除标准

  • Allergy or contraindication to lidocaine

研究组 & 干预措施

Lidocaine group

Active Comparator

The group of patient will receive lidocaine spraying on vocal cord before intubation

干预措施: Normal Saline (0.9% NaCl) (Drug)

Control group

Placebo Comparator

The group of patient will receive normal saline spraying on vocal cord before intubation

干预措施: Lidocaine %2 ampoule (Drug)

结局指标

主要结局

post-intubation hypertension

时间窗: From enrollment to the end of surgery

defined as an increase in systolic blood pressure of more than 20% from baseline

changes in mean arterial pressure before and after intubation

时间窗: From enrollment to the end of surgery

objective pain indices (Surgical Pleth Index)

时间窗: From enrollment to the end of surgery

次要结局

  • post-intubation hypotension(From enrollment to postoperative day 1)
  • pain on swallowing(From enrollment to postoperative day 1)
  • postoperative sore throat(From enrollment to postoperative day 1)
  • hoarseness(From enrollment to postoperative day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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