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临床试验/NCT05863416
NCT05863416已完成4 期

Adjunctive Dexmedetomidine Infusion in Non-intubated Video-assisted Thoracoscopic Surgery

Tri-Service General Hospital2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年4月23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
144
试验地点
2
主要终点
Cough

研究概览

简要总结

This prospective study aims to evaluate the effectiveness of intraoperative DEX for postoperative analgesia and recovery after non-intubated VATS. In addition, the investigators observe the impact of DEX on anesthetic requirements, hemodynamic parameters, and adverse events during non-intubated VATS.

详细描述

The non-intubated thoracoscopic approach has been adapted for use with major lung resections. The non-intubated VATS tries to minimize the adverse effects of tracheal intubation and general anesthesia, such as intubation-related airway trauma, ventilation-induced lung injury, residual neuromuscular blockade, and postoperative nausea and vomiting. An adequate analgesia allows VATS to be performed in sedated patients and the potential adverse effects related to general anesthesia and selective ventilation can be avoided. Dexmedetomidine (DEX), a highly selective alpha-2 receptor agonist, is increasingly used in anesthesia with sedative, hypnotic, anxiolytic, sympatholytic, and analgesic effects. It can also attenuate perioperative stress and inflammation and preserve the immunity of surgical patients, which may contribute to reduced postoperative complications and improved clinical outcomes. This study aims to evaluate the effectiveness of intraoperative DEX for postoperative analgesia and recovery after non-intubated VATS. In addition, the investigators observe the impact of DEX on anesthetic requirements, hemodynamic parameters, and adverse events during non-intubated VATS.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) score of I-III patients receiving video-assisted thoracoscopic surgery

排除标准

  • Age < 18 or > 80 years
  • ASA classifications > III
  • Pregnancy
  • Known allergies to any drugs used in the study
  • Emergency surgery
  • Patient refusal
  • Chronic pain history

研究组 & 干预措施

Group Saline

Active Comparator

Propofol-based total intravenous anesthesia with saline infusion

干预措施: Dexmedetomidine infusion (Drug)

Group Dexmedetomidine

Experimental

Propofol-based total intravenous anesthesia with dexmedetomidine infusion

干预措施: Dexmedetomidine infusion (Drug)

结局指标

主要结局

Cough

时间窗: Intraoperative period

The incidence of cough reflex during surgery and severity Cough severity: 1=none, 2=slight, 3=moderate, 4=severe

次要结局

  • Total fentanyl consumption(Intraoperative period)
  • Intraoperative fentanyl consumption(Intraoperative period)
  • Total propofol consumption(Intraoperative period)
  • Intraoperative adverse events(Intraoperative period)
  • Postoperative opioid requirement(Postoperative 48 hours)
  • Postoperative numeric rating scale(Postoperative 48 hours)

研究者

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

Wei-Cheng Tseng

Principal Investigator

Tri-Service General Hospital

研究点 (2)

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Dexmedetomidine in Non-intubated VATS | 临床试验