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临床试验/IRCT20230809059105N1
IRCT20230809059105N1招募中Unknown

A double-blind randomized placebo - controlled trial of melatonin as premedication agent in Caesarean section

Alayen universty0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 no limit(—)
性别
Female

入选标准

  • The study's inclusion criteria encompassed individuals who fulfilled the subsequent requirements: age exceeding 18 years, categorized as ASA I or ASA II (pertaining to the American Society of Anesthesiologists Physical Status Classification System, signifying a patient in good health or with mild systemic illness, respectively), pregnancy at a gestational age surpassing 37 weeks, unbroken membranes, scheduled surgical procedures, patient agreement and contentment with study participation, and women with a solitary pregnancy.

排除标准

  • The exclusion criteria for the study encompass several factors, including ASA III or higher, which indicates severe systemic disease or a constant threat to life, documented drug allergy to melatonin or any other study medications, contraindications for spinal anesthesia such as spinal abnormalities or infections, inability of the patient to respond or demonstrate awareness to the questions rose, a history of mental or neurological diseases that could affect the patient's ability to participate or comprehend the study procedures, addiction to substances that could interfere with the study outcomes, disapproval or dissatisfaction expressed by the patient regarding their involvement in the study, presence of congenital malformations in the fetus detected during routine prenatal screening, inability to provide informed consent due to intellectual impairment or other factors, significant heart disease that could pose additional risks during the surgical procedure.

研究者

发起方
Alayen universty

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