A Randomized Comparative Study of Analgesic Effect of Addition of Two Different Doses of Dexmedetomidine as an Adjuvant to Intrathecal Hyperbaric Ropivacaine for Infraumbilical Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia.
研究概览
简要总结
A randomized, double blind, parallel group clinical trial designed to compare the analgesic efficacy of two different doses of dexmedetomidine (2 mcg vs 4 mcg) as an adjuvant to intrathecal hyperbaric ropivacaine in patients undergoing infraumbilical surgeries. The primary outcomes are time to first rescue analgesia and total number of rescue analgesics required in 24 hours. Secondary outcomes include onset and duration of sensory and motor block, hemodynamic changes, sedation score, VAS score, and adverse effects. A total of 64 patients will be enrolled and randomized into two groups of 32 each. The study will be conducted at Jhalawar Medical College and Associated Hospitals, Rajasthan, after approval by the Institutional Ethics Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I & II Weight between 45–70 kg Patients scheduled for elective infraumbilical surgeries under spinal anesthesia.
排除标准
- •Patient refusal Sepsis or infection at puncture site Severe systemic illness (renal, hepatic, cardiac, respiratory) Raised intracranial tension Coagulopathy Allergy to study drugs Failed spinal block.
结局指标
主要结局
Time to first rescue analgesia.
时间窗: Assessed at regular intervals up to 24 hours postoperatively.
Total number of rescue analgesic doses in first 24 hours.
时间窗: Assessed at regular intervals up to 24 hours postoperatively.
次要结局
- 1. Onset of sensory block.(2. Duration of sensory block.)
研究者
Dr Sakshi Singh
Jhalawar Medical College