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临床试验/CTRI/2024/05/068112
CTRI/2024/05/068112已完成4 期

Evaluation of varied doses of Intravenous Dexmedetomidine in attenuating post spinal anesthesia shivering response in patients undergoing Elective Lower Segment Cesarean Section

Kasturba Medical College, Manipal, MAHE1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年6月9日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Shivering score will be measured according to crossley and mahajan grading for shivering

研究概览

简要总结

Shivering during Cesarean delivery under neuraxial anesthesia occurs frequently and can be very distressing.  Its origin is both thermogenic and non-thermogenic. Internal redistribution of core temperature, loss of thermoregulatory vasoconstriction below the level of blockade, and a decrease of the vasoconstriction threshold are possible explanations for shivering under neuraxial anesthesia. Active warming methods, such as forced air blankets, are an intuitive and attractive solution to such a problem; nevertheless, studies regarding their effectiveness in the context of parturient undergoing Cesarean delivery have been conflicting and do not address the complex pathophysiology of shivering.

This study involves the use of drug dexmedetomidine and has been approved by FDA for intravenous use purpose. Through its action on the alpha 2b-adrenoceptor in the hypothalamus, dexmedetomidine suppresses spontaneous firing rate of neurons, decreases central thermosensitivity, and reduces vasoconstriction and shivering thresholds. Two different doses will be compared in terms of time required for observable decrease in shivering caused by central neuraxial block in LSCS patients. Along with shivering, sedation and incidence of adverse events such as nausea, vomiting and respiratory depression will also be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • ASA physical status 2 patients above 18 years of age who shiver during elective LSCS that continued to cord clamping.

排除标准

  • Unscheduled caesarean deliveries History of chronic nausea or itching in pregnancy Chronic opioid use History of cardiac, renal or hepatic disease requiring follow up or medications Coagulation disorders History of febrile illness.

结局指标

主要结局

Shivering score will be measured according to crossley and mahajan grading for shivering

时间窗: At 5 minutes interval till 15 minutes and then at 30 minutes and 60 minutes

次要结局

  • Sedation score(At 5 minutes interval till 15 minutes and then at 30 minutes and 60 minutes)

研究者

发起方
Kasturba Medical College, Manipal, MAHE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vinay Kejdiwal

Kasturba Medical College, Manipal

研究点 (1)

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