关键词: anaesthesia in obstetrics clinical trial maternal medicine protocols & guidelines vascular medicine

Mesh : Humans Anesthesia, Spinal / methods adverse effects Shivering / drug effects Cesarean Section / adverse effects Female Double-Blind Method Pregnancy Norepinephrine / therapeutic use China / epidemiology Tertiary Care Centers Hypothermia / prevention & control Phenylephrine / therapeutic use Adult Anesthesia, Obstetrical / methods adverse effects Vasoconstrictor Agents / therapeutic use Randomized Controlled Trials as Topic

来  源:   DOI:10.1136/bmjopen-2023-083202   PDF(Pubmed)

Abstract:
BACKGROUND: Peripheral vasodilation causes a redistribution of body temperature from the core to the periphery, resulting in shivering and hypothermia. These are normal pathological and physiological processes during spinal anaesthesia. Two drugs, norepinephrine and phenylephrine, have peripheral vasoconstrictive effects. It is unclear the effects of norepinephrine and phenylephrine on shivering and hypothermia in patients undergoing caesarean section under spinal anaesthesia.
UNASSIGNED: 240 eligible parturients will be recruited for this randomised, double-blind, controlled trial and randomly assigned to either the norepinephrine or phenylephrine groups. The primary outcome will be the incidence of shivering while secondary outcomes will include the severity of shivering, rectal temperature, incidence of hypothermia and umbilical artery blood pH value.
BACKGROUND: The Institutional Ethics Committee of The Second People\'s Hospital of Hefei approved the trial protocol (ID: 2023-093). The results will be published in a compliant journal. The original data will be released in December 2029 on the ResMan original data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).
BACKGROUND: ChiCTR2300077164.
摘要:
背景:外周血管舒张导致体温从核心到外围的重新分布,导致颤抖和体温过低。这些是脊髓麻醉期间的正常病理和生理过程。两种药物,去甲肾上腺素和去氧肾上腺素,有外周血管收缩作用.目前尚不清楚去甲肾上腺素和去氧肾上腺素对脊柱麻醉下剖腹产患者寒战和体温过低的影响。
将招募240名符合条件的产妇,双盲,对照试验,随机分配到去甲肾上腺素或去氧肾上腺素组。主要结果将是寒战的发生率,而次要结果将包括寒战的严重程度,直肠温度,低体温发生率和脐动脉血pH值。
背景:合肥市第二人民医院伦理委员会批准了试验方案(ID:2023-093)。结果将发表在合规期刊上。原始数据将于2029年12月在中国临床试验注册中心ResMan原始数据共享平台(http://www.medresman.org.cn)。
背景:ChiCTR2300077164。
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