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临床试验/NCT07663149
NCT07663149已完成不适用

Effectiveness of Continuous Phenylephrine in Preventing Shivering After Spinal Anesthesia in Cesarean Section

Indonesia University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2026年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1

研究概览

简要总结

This study aims to evaluate the effectiveness of continuous phenylephrine infusion at 50 mcg/min in preventing shivering after spinal anesthesia in cesarean section.

This study was an open-label randomized clinical trial involving patients undergoing cesarean section under spinal anesthesia. Subjects were allocated into two groups: without phenylephrine and continuous phenylephrine infusion at 50 mcg/min. The primary outcome was the incidence of shivering during observation, assessed using the Crossley and Mahajan scale. Secondary outcomes included hypotension, ephedrine requirement, hemodynamic adverse events, and nausea vomiting.

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
None

入排标准

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

入选标准

  • Females aged 18-50 years.
  • Patients undergoing a Cesarean section procedure under spinal anesthesia.
  • Patients who are not in labor (non-labor).
  • Patients willing to participate in this study.

排除标准

  • Patients with contraindications to phenylephrine.
  • Patients with allergies to the study medications.
  • Presence of fever (temperature >37.5°C) or hypothermia (temperature <35°C).
  • American Society of Anesthesiologists (ASA) score of III or higher.
  • Patients with a history of untreated thyroid disease.
  • Patients with a history of autonomic nervous system neuropathy.
  • Hypertension in pregnancy (or gestational hypertension).
  • Body Mass Index (BMI) greater than 35 kg/m².

研究者

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

Alfan Mahdi Nugroho

dr. Alfan Mahdi Nugroho Sp.An-TI, Subsp.AO(K), Subsp.AR(K)

Indonesia University

研究点 (1)

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