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临床试验/NCT07145814
NCT07145814已完成不适用

Dexmedetomidine Dose-Dependent Modulation of Lung Function and AQP1 Expression During One-Lung Ventilation in Adults Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial

People's Hospital of Guangxi Zhuang Autonomous Region1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月5日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
aquaporin-1 (AQP1) expression during one-lung ventilation in thoracoscopic surgery

研究概览

简要总结

This randomized controlled trial evaluated the dose-dependent effects of dexmedetomidine (DEX) on pulmonary function and aquaporin-1 (AQP1) expression during one-lung ventilation (OLV) in thoracoscopic surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status I or II
  • Age 40-70 years
  • Body mass index (BMI) 18-30 kg/m²

排除标准

  • Preoperative tumor radiotherapy or chemotherapy
  • Immune or endocrine disorders
  • Hepatic or renal dysfunction
  • Preoperative corticosteroid use
  • Recent respiratory infection or chronic lung disease
  • Sick sinus syndrome or atrioventricular block
  • Preoperative anemia (hemoglobin < 90 g/L)

研究组 & 干预措施

Placebo group

Placebo Comparator

Placebo group received an equivalent volume of 0.9% saline.

干预措施: 0.9 % saline (Drug)

dexmedetomidine Low Dose group

Experimental

Following Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation.

干预措施: dexmedetomidine 0.3 µg/kg/h (Drug)

dexmedetomidine high dose group

Experimental

Following Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation.

干预措施: dexmedetomidine 0.5 µg/kg/h (Drug)

结局指标

主要结局

aquaporin-1 (AQP1) expression during one-lung ventilation in thoracoscopic surgery

时间窗: before one-lung ventilation, Immediately after lobectomy

AQP1 expression, serving as an indicator of pulmonary interstitial water permeability, was assessed by immunohistochemistry (IHC) on lung tissue samples. Two histologically normal specimens (1×1×1 cm³ each) were collected per patient: 1) Before one-lung ventilation: ≥ 5 cm from tumor margin in planned resection area; 2) Immediately after lobectomy: ≥ 5 cm from margin in isolated lung. Tissues were fixed in 10% neutral buffered formalin (24 hours), paraffin-embedded, and sectioned (3 μm). Five random high-power fields (HPF, 400x) per section were evaluated. The percentage of positive cells (0: 0-25%; 1: 26-50%; 2: 51-75%; 3: 76-100%) and staining intensity (0: none; 1: light yellow; 2: brown; 3: dark brown) were scored. The total IHC score (range 0-9) was calculated as (percentage score x intensity score); specimens were classified as low (≤ 4) or high (\> 4) AQP1 expression.

次要结局

  • Pulmonary function during one-lung ventilation in thoracoscopic surgery, including lung compliance (Cdyn)(pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation)
  • Pulmonary function during one-lung ventilation in thoracoscopic surgery, including respiratory index (RI), and oxygenation index (OI).(pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation)

研究者

发起方
People's Hospital of Guangxi Zhuang Autonomous Region
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuanqiang Li

Professor

People's Hospital of Guangxi Zhuang Autonomous Region

研究点 (1)

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