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临床试验/NCT05481281
NCT05481281Unknown3 期

Comparison Of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia

Hamdard University0 个研究点目标入组 104 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
104
主要终点
Change in Shivering grade

研究概览

简要总结

comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia.

详细描述

In this study the participants aim to Compare Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

the drugs will be prepared by anesthesiologist who will not be the part of the study and these drugs will be injected by another anesthesiologist who will be blinded to the drugs and will be participating into the study.

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients of age 45-55 years requiring vaginal hysterectomy
  • American Society of Anesthesiology (ASA) of Grade I-II

排除标准

  • Patients unwilling or non-cooperative for spinal anesthesia
  • Patients with uncontrolled hypertension, vascular or coronary disease,
  • patients with increased intraocular or intracranial pressure
  • Patients with known bleeding and psychiatric disorders
  • Patients taking anti platelets drugs.

研究组 & 干预措施

Group Dexmedetomidine

Experimental

Group Dexmedetomidine receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion

干预措施: Dexmedetomidine (Drug)

Group Ketamine

Experimental

Group Ketamine receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion

干预措施: Ketamine (Drug)

结局指标

主要结局

Change in Shivering grade

时间窗: Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively

Shivering of patients will be grouped into five grades; Grade 0: lack of shivering, Grade I: slight shivering (inconsiderable yet apparent peripheral vasoconstriction), Grade II: medium level shivering (muscular activity in one muscle group only), Grade III: severe shivering (muscular activity in more than one muscle group without generalized shivering), Grade IV: generalized shivering.

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

Dr. Nida Shahid

Assistant Professor, Anesthesiology

Hamdard University

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