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临床试验/NCT06037135
NCT06037135已完成不适用

The Effects of Perioperative Dexmedetomidine Infusion on Hemodynamic Stability During Laparoscopic Adrenalectomy for Pheochromocytoma: a Randomized Study

Yonsei University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

研究概览

简要总结

The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • ages of 20 and 70
  • American Society of Anesthesiologists(ASA) physical status classification I to III,
  • planned laparoscopic adrenalectomy for pheochromocytoma.

排除标准

  • emergency operation,
  • re-operation,
  • combined surgery with other departments,
  • body mass index (BMI) >32 kg/m2,
  • history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
  • uncontrolled hypertension (diastolic blood pressure >110mmHg)
  • bradycardia (heart rate < 40 beats per minute),
  • history of heart failure, hepatic and/or renal failure,
  • history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
  • history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.

研究组 & 干预措施

dexmedetomidine group

Experimental

In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.

干预措施: dexmedetomidine (Drug)

Control group

Active Comparator

In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.

干预措施: 0.9% normal saline (Drug)

结局指标

主要结局

Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)

时间窗: during operation

Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)

时间窗: during operation

Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))

时间窗: during operation

Intraoperative hemodynamic stability (maximum HR during surgery)

时间窗: during operation

Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)

时间窗: during operation

Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)

时间窗: during operation

次要结局

  • levels of catecholamines(immediately after the completion of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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