CTRI/2025/11/097400尚未招募2/3 期
Efficacy Of Oral Clonidine On Intraoperative Hemodynamics And Postoperative Analgesia In Patients Undergoing Lumbar Spine Surgeries.
Amruta Chaudhari1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年12月24日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Efficacy Of Oral Clonidine On Intraoperative Hemodynamics
研究概览
简要总结
It is a prospective, randomized, double blinded comparative study to compare the effects of oral clonidine on intraoperative hemodynamics and postoperative analgesia in placebo controlled study in patients undergoing lumbar spine surgery.
Parameters that will be compared between the two groups will be the pre-operative , after induction , after 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hour and postoperatively to see intraoperative hemodynamics and postoperative analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I or II fit patients.
- •Ages between 18 and 60 years.
- •Patients undergoing lumbar spine surgery.
- •Hemodynamically stable patients with all routine investigations within normal limits without any other comorbidities.
- •Patients who are not on any cardiac related drugs.
- •Availability of written informed consent from concerned patients.
排除标准
- •Patients below the age of 18 and above the age of 60 year 2) ASA III and IV patients 3) Patients with liver dysfunction 4) Patients with the history of allergy to the study medication 5) Pregnancy 6) Patients undergoing scoliosis surgery or more than 5 level of fusion 7) Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic hypertension, pulmonary disorders, etc.
- •Patients with spine deformities or local skin interactions overlying the lumbar vertebral region 9) Patients with bleeding or coagulation disorders.
结局指标
主要结局
Efficacy Of Oral Clonidine On Intraoperative Hemodynamics
时间窗: Postoperative Analgesia In Patients Undergoing Lumbar Spine Surgeries
次要结局
- total doses of fentanyl used intraoperatively(compare the incidence of adverse events)
研究者
Amruta Chaudhari
Dr. D.Y. Patil Medical College ,Hospital and Research Centre
研究点 (1)
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