跳至主要内容
临床试验/NCT04133961
NCT04133961已完成不适用

Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Universiti Kebangsaan Malaysia Medical Centre1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年6月12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
发起方
入组人数
118
试验地点
1
主要终点
Presence and intensity of shivering

研究概览

简要总结

Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.

详细描述

This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • More than 18 years of age
  • American Society of Anesthesiologists (ASA) II patients
  • Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia

排除标准

  • Patients with contraindication to phenylephrine
  • Patients with evidence of fever or infection, or hypothermia preoperatively
  • Height <150cm

研究组 & 干预措施

Group A (Phenylephrine)

Experimental

Phenylephrine infusion started immediately after administration of spinal block

干预措施: Phenylephrine (Drug)

Group B (Saline)

Placebo Comparator

Normal saline infusion started immediately after administration of spinal block

干预措施: Normal saline (Drug)

结局指标

主要结局

Presence and intensity of shivering

时间窗: 2 hours

Any presence of shivering intraoperatively is recorded. The intensity of shivering is recorded based on the Bedside Shivering Assessment Scale (BSAS) with a scoring of 0-3 (0 = no shivering, 1 = shivering localised to neck and/or thorax, 2 = shivering involves gross movement of upper extremities, 3 = shivering involves gross movements of the trunk, upper and lower extremities).

次要结局

  • Change in patient's core and skin temperature(2 hours)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Intraoperative Phenylephrine Infusion to Reduce... | 临床试验