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临床试验/NCT06612996
NCT06612996尚未招募4 期

Comparative Study Between Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering Post Intrathecal Anesthesia a Randomized Clinical Study

Al-Azhar University0 个研究点目标入组 180 人开始时间: 2024年10月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
180
主要终点
Shivering score

研究概览

简要总结

The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.

排除标准

  • history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever >38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake

研究组 & 干预措施

Tramadol group

Experimental

Intravenous Tramadol

干预措施: Tramadol (Drug)

Magnesium sulphate group

Experimental

Intravenous Magnesium Sulphate

干预措施: Magnesium sulphate (Drug)

Control group

Placebo Comparator

Saline

干预措施: Saline (Other)

结局指标

主要结局

Shivering score

时间窗: 90 minutes postoperatively

Shivering score

次要结局

未报告次要终点

研究者

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

Warda Demerdash Khalifa Ali

Dr

Al-Azhar University

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