临床试验/CTRI/2025/02/081101

CTRI/2025/02/081101尚未招募4 期

Intrathecal Nalbuphine versus Dexmedetomidine as adjuvants with Bupivacaine in prevention of Post Spinal Shivering - A Randomized Controlled Trial

Aarupadai veedu medical college and hospital1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2025年2月28日最近更新: 2025年6月26日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 72
试验地点: 1
主要终点: To assess the incidence and severity of post spinal shivering with intrathecal Nalbuphine and Dexmedetomidine as an adjuvant with Bupivacaine in spinal anaesthesia.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Shivering is often seen after spinal anaesthesia and it is associated with adverse effects and causes discomfort in post spinal patients. In this study we comparing the efficacy of Intrathecal Nalbuphine and Dexmedetomidine for prevention of post spinal shivering.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

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

入选标准

•Age group 18 to 60 years
•ASA I and ASA II
•Patient planned for elective lower abdominal and lower limb surgeries under spinal anaesthesia.

排除标准

•Patient refusal
•Contraindication for spinal anaesthesia
•BMI more than 30.

结局指标

主要结局

To assess the incidence and severity of post spinal shivering with intrathecal Nalbuphine and Dexmedetomidine as an adjuvant with Bupivacaine in spinal anaesthesia.

时间窗: 7 hours intraoperatively and postoperatively

次要结局

To assess:(Hemodynamic parameters (Heart Rate, Mean Arterial Blood Pressure, Oxygen Saturation, Respiratory Rate and Temperature))

研究者

发起方

Aarupadai veedu medical college and hospital

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

Dr Nivetha Manikandan

Aarupadai veedu medical College and hospital

研究点 (1)

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