跳至主要内容
临床试验/CTRI/2024/04/065749
CTRI/2024/04/065749尚未招募Unknown

Comparison of intravenous Dexmedetomidine vs Tramadol as anti-shivering agent following spinal anesthesia

Eras medical college and hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年4月24日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
the primary outcome of the study is to compare the effectiveness of intravenous dexmedetomidine versus tramadol as a anti shivering agent post spinal anesthesia and better agent that helps in subsiding the shivering faster with least amount of side effects.

研究概览

简要总结

.Shivering is a common postanesthesia adverse event with an incidence of 40–70%.

Shivering is not only physically distressing for the patient, but can have various other detrimental effects. It may lead to pain, patient discomfort, impede monitoring techniques, increase intraocular and intracranial pressures, double or even triple oxygen consumption and carbon dioxide production, which might pose difficulties in patients with existing intrapulmonary shunts, fixed cardiac output or limited respiratory reserve.

Therefore by comparing the anti-shivering effect of Dexmedetomidine vs Tramadol post spinal anesthesia, a outcome can be achieved for a better anti-shivering agent amongst the two agents.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American society of anesthesiologists (ASA) physical status grade 1 and 2, patients who develop shivering post sub arachnoid block (spinal anesthesia).

排除标准

  • patient refusal, pregnancy, patients with known hypersensitivity to study drugs, ischemic heart disease, hepatic disease, hyperthyroidism, hypothyroidism, urinary tract infection, diabetes mellitus, known history of substance or alcohol abuse.

结局指标

主要结局

the primary outcome of the study is to compare the effectiveness of intravenous dexmedetomidine versus tramadol as a anti shivering agent post spinal anesthesia and better agent that helps in subsiding the shivering faster with least amount of side effects.

时间窗: time noted after onset of shivering and time taken to subside the shivering. vitals measured at every 5 minute interval till 30 minutes and every 15 minutes till end of surgery.

次要结局

  • side effects to be noted such as nausea, vomiting, bradycardia etc(at the end of study)

研究者

发起方
Eras medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ruchita Sunil Raikar

junior resident

研究点 (1)

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