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临床试验/NCT05616364
NCT05616364尚未招募2 期

Comparison of the Efficacy of Intravenous Dexmedetomidine and Tramadol in Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment Cesarean Section

Sana Bahadur0 个研究点目标入组 100 人开始时间: 2023年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
主要终点
Assessment of post spinal shivering by observing grades of shivering

研究概览

简要总结

When opposed to GA,SA is recommended during c section. Shivering is more prevalent and inconvenient complication of spinal anaesthesia, with 40 to 70% incidence rate. Tramadol has been proven to be beneficial in preventing post spinal shivering. Dexmedetomidine is a sedative, analgesic, anxiolytic, sympatholytic and opioid-sparing alpha adrenergic agonist. It has been shown to lower the threshold for shivering. The study aims to search for best drug for blunting shivering response.

详细描述

When opposed to general anaesthesia (GA), spinal anaesthesia (SA) is recommended during caesarean section (CS) because of various advantages, including the prevention of GA-related neurotoxicity, its early onset and ease of administration, and the reduction of post-operative pain. Intraoperative shivering is the most prevalent irritating and inconvenient complication of spinal anaesthesia, and it is a very distressing experience that causes physiological stress to both patients and perioperative physicians and operating surgeons. Shivering is a skeletal muscular movement that occurs involuntarily and repeatedly. It's a common post-anesthesia adverse effect, with a 40-70% incidence rate.Shivering is not only physically unpleasant for the sufferer, but it can also have several negative consequences. It can cause pain, and discomfort for patients, obstruct monitoring techniques, raise intraocular and intracranial pressures, and double or even triple oxygen and carbon dioxide intake.Various pharmacological and non-pharmacological strategies for managing intraoperative shivering are discussed.

Tramadol, a centrally acting analgesic with -opioid agonist properties and little action on kappa and delta receptors, has been proven to be beneficial in preventing post-spinal shivering. The method of action is thought to be through a modulatory influence on central monoaminergic pathways, which inhibits noradrenaline and serotonin neuronal absorption in the spinal cord while boosting hydroxyltryptamine production, resetting the body temperature regulatory center.However, it has many side effects, including nausea, vomiting, and dizziness, which add to the patient's pain. Hence research into novel solutions with adequate safety and effectiveness is strongly advised. In this sense, despite taking into account the gold standard for post spinal shivering control is pethidine. it is contraindicated in breastfeeding which is both legally and ethically challenging for women.

Dexmedetomidine is a sedative, analgesic, anxiolytic, sympatholytic, and opioid-sparing alpha 2 adrenergic agonist with good selectivity and specificity.It has been shown to lower the threshold for shivering.Dexmedetomidine does not affect the locus ceruleus of the spinal cord, and it does not cause respiratory depression. In postoperative patients, dexmedetomidine lowers cortisol and norepinephrine levels, as well as blood glucose, interleukin (IL)-6, tumour necrosis factor-a, and C-reactive protein, and raises interleukin-10. Moreover, because Dexmedetomidine does not affect upper airway reflexes, it is an excellent option.It was believed that the sedative impact of intravenous injection on newborn infants was very minimal and could be disregarded due to the delayed sedative effects.

These drugs have well-defined roles to blunt the "shivering response" and hence have been used in different comparative studies to develop the single best drug of choice. Yet, there is no consensus over a single drug. In our research, we intend to compare IV Tramadol and IV Dexmedetomidine for controlling post spinal shivering in obstetric patients. The study aims to search for the best drug for blunting the shivering response, which may prove fatal in any patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient who will give consent
  • ASA 2 patients
  • Female gender of age 18 to 38

排除标准

  • Patient allergic to any drugs
  • Uncontrolled HTN
  • Antepartum
  • Cardiomyopathy
  • Peripartum haemorrhage
  • Eclampsia
  • Patients refuse to give consent

研究组 & 干预措施

Dexmedetomidine

Experimental

Dexmedetomidine is a sedative, analgesic, anxiolytic, sympatholytic, and opioid-sparing alpha 2 adrenergic agonist with good selectivity and specificity.It has been shown to lower the threshold for shivering. Dexmedetomidine does not affect the locus ceruleus of the spinal cord, and it does not cause respiratory depression. [8] In postoperative patients, dexmedetomidine lowers cortisol and norepinephrine levels, as well as blood glucose, interleukin (IL)-6, tumour necrosis factor-a, and C-reactive protein, and raises interleukin-10. Moreover, because Dexmedetomidine does not affect upper airway reflexes, it is an excellent option.It was believed that the sedative impact of intravenous injection on newborn infants was very minimal and could be disregarded due to the delayed sedative effects

干预措施: Dexmedetomidine injection (Drug)

Tramadol

Experimental

Tramadol, a centrally acting analgesic with -opioid agonist properties and little action on kappa and delta receptors, has been proven to be beneficial in preventing post-spinal shivering. The method of action is thought to be through a modulatory influence on central monoaminergic pathways, which inhibits noradrenaline and serotonin neuronal absorption in the spinal cord while boosting hydroxyltryptamine production, resetting the body temperature regulatory center. [3] However, it has many side effects, including nausea, vomiting, and dizziness, which add to the patient's pain. [5] Hence research into novel solutions with adequate safety and effectiveness is strongly advised. In this sense, despite taking into account the gold standard for post spinal shivering control is pethidine. it is contraindicated in breastfeeding which is both legally and ethically challenging for women.

干预措施: Tramadol (Drug)

结局指标

主要结局

Assessment of post spinal shivering by observing grades of shivering

时间窗: 10 minutes

Control of post spinal shivering Dexmedetomidine and tramadol for post spinal shivering

次要结局

未报告次要终点

研究者

发起方
Sana Bahadur
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Sana Bahadur

Dr.Sana bahadur

Sheikh Zayed Medical College

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